Novartis 2019: Innovating for challenging healthcare issues

 

Novartis is investing in the most promising frontiers of science, the most exciting innovations in the business of medicine, and the most significant healthcare needs.

 

 

Novartis AG

Lichtstrasse 35
CH-4056 Basel, Switzerland
Telephone: +41 61 324 11 11
Website: novartis.com

 

Best-Selling Products

Product	2018 Sales	2017 Sales
Gilenya	$3,341	$3,185
Cosentyx	$2,837	$2,071
Lucentis	$2,046	$1,888
Tasigna	$1,874	$1,841
Sandostatin	$1,587	$1,612
Gleevec/Glivec	$1,561	$1,943
Afinitor/Votubia	$1,556	$1,525
Galvus, Eucreas	$1,284	$1,233
Tafinlar/Mekinist	$1,155	$873
Exjade	$1,099	$1,059
Xolair	$1,039	$920
Entresto	$1,028	$507
Diovan, Diovan HCT	$1,023	$957
Exforge	$1,022	$960
Jakavi	$922	$777
Votrient	$828	$808
Travoprost Group	$517	$589

All sales are in millions of dollars.

 

Financial Performance

	2018	2017
Revenue	$51,900	$49,109
Net income	$12,611	$7,703
Diluted EPS	$5.38	$3.25
R&D expense	$9,074	$8,972

	1H 2019	1H 2018
Revenue	$22,923	$22,287
Net income	$8,565	$9,793
Diluted EPS	$3.66	$4.17
R&D expense	$4,350	$4,108

 All sales are in millions of dollars except EPS.

 

Outcomes Creativity Index Score: 40
Manny Awards – 7
Cannes Lions – 10
LIA: Health & Wellness – N/A
Clio Health – N/A
One Show: HW&P – N/A
MM&M Awards – 6
Global Awards – 5
Creative Floor Awards – 12

 

Novartis took another step forward in fulfilling management’s long-term strategy to build a leading, focused medicines company powered by advanced therapy platforms and data science after completing the spin-off of the eye-care device business Alcon. The spin-off, which was finalized on April 9, 2019, enables shareholders to benefit from a standalone Alcon and a Novartis with capital and management attention fully concentrated on medicines. At the same time, Novartis retains a leading ophthalmology pharmaceuticals business and attractive pipeline, according to the executive leadership team.

“The successful execution of the Alcon spin-off allows Novartis to fully focus its capital allocation and management attention on medicines,” Novartis executives say. “The spin-off gives Novartis a financial profile closer to its pharmaceutical industry peers, including higher group margins. As a focused medicines company, Novartis is well-positioned for sustained top- and bottom-line growth and plans to improve Innovative Medicines core margins into the mid-30s by 2022.”

The next step towards meeting Novartis’ long-term business goal will occur upon the divestment of Sandoz’s U.S. oral solids and dermatology portfolio, to be completed to Aurobindo Pharma USA before year-end 2019.

Novartis’ revamped business structure will then consist of two divisions – Innovative Medicines and Sandoz – supported by functional organizations with global scale. Comprising two business units – Novartis Pharmaceuticals and Novartis Oncology – the Innovative Medicines Division commercializes innovative patented medicines to enhance health outcomes for patients and healthcare professionals. Meanwhile, Sandoz is a worldwide leader in generic pharmaceuticals and biosimilars that pioneers novel approaches to help people around the globe access high-quality medicines. During 2018, the Innovative Medicines business generated net sales of $34.89 billion and Sandoz accounted for $9.86 billion.

Management says there are five priorities that are shaping Novartis’ future and helping continue to create value for the company, shareholders and society: “Unleash the power of our people; deliver transformative innovation; embrace operational excellence; go big on data and digital; and build trust with society.”

Novartis products reach more than 750 million people spanning across 155 countries. The company is concentrated in the fields of cancer; cardiovascular, renal, and metabolism; immunology and dermatology; neuroscience; ophthalmology; and respiratory. The medicines portfolio is bolstered by one of the industry’s most competitive and innovative pipelines consisting of more than 200 projects in clinical development.

Novartis touts an industry-leading, catalyst-rich pipeline with 10 potential blockbuster launches expected in the next two years and another 20 potential blockbusters on the horizon. Of these potential blockbuster launches, four were planned for 2019, including brolucizumab (RTH258). RTH258 is part of the leading ophthalmology pharma business retained by Novartis, with 2018 sales totaling $4.6 billion and a pipeline of potential novel treatments for presbyopia, dry eye, and genetic diseases.

According to the managerial team, Novartis has a sound strategy to navigate a world with a growing, aging population and continuously evolving healthcare needs. “Our strategy supports the Novartis purpose and is centered around four key areas: holding ourselves to the highest ethical standards, being part of the solution on pricing and access to medicines, helping tackle global health challenges and being a responsible citizen.”

2019 Performance and Outlook

Management says Novartis delivered an exceptional first-half 2019 performance as a focused medicines company with strong sales and productivity driving double digit core operating income growth with margin expansion. Net sales totaled $22.9 billion (+3 percent, +8 percent cc) during the first six months of 2019, driven by volume growth of 11 percentage points (cc), mainly from Cosentyx, Entresto, and Lutathera. According to the company, strong volume growth was partly offset by the negative impacts of pricing (-2 percentage points cc) and generic competition (-1 percentage point cc).

Following the Alcon spin-off, a one-time non-cash IFRS gain of $4.7 billion was recorded in discontinued operations for Novartis. Discontinued operations net sales during the first six months of 2019 came in at $1.8 billion compared to $3.6 billion in 2018.

Innovative Medicines generated net sales of $18.1 billion (+5 percent, +10 percent cc) in the first six months of 2019. Pharmaceuticals BU rose 10 percent (cc), driven by Cosentyx and Entresto. Oncology increased 9 percent (cc) fueled by Lutathera, as well as Promacta/Revolade, Tafinlar + Mekinist, and Kisqali. Volume contributed 11 (cc) percentage points to first-half 2019 sales growth. Generic competition had a negative impact of 1 (cc) percentage point, and net pricing had a negligible impact.

On a regional basis for Innovative Medicines, Novartis says U.S. first-half 2019 sales of $6.3 billion (+12 percent) delivered a strong performance driven by Cosentyx, Entresto and Lutathera. Europe sales totaling $6.4 billion (+2 percent, +11 percent cc) benefited from a continued strong performance of Entresto, Lucentis, Tafinlar + Mekinist, and Cosentyx. Japan sales during January-June 2019 came in at $1.2 billion (0 percent, +1 percent cc). Emerging Growth Markets sales grew +2 percent and +11 percent cc year-over-year, led by double-digit cc growth in China.

Sandoz net sales during January-June 2019 amounted to $4.8 billion (-4 percent, +1 percent cc), driven by volume growth of 9 percentage points (cc) partially offset by 8 percentage points (cc) of price erosion, mainly in the United States. Excluding the United States, net sales increased 6 percent (cc). Global sales of Biopharmaceuticals rose 14 percent (cc) compared to the first-half 2018 result, driven by continued strong double-digit growth in Europe from Rixathon (rituximab), Hyrimoz (adalimumab), and Erelzi (etanercept). According to the company, launch roll-outs in Asia/Africa/Australasia contributed to growth.

Retail sales for Sandoz were reported at $3.8 billion (-6 percent, -1 percent cc) for the first six months of 2019, as the decline in the United States (-8 percent) was mostly offset by growth in the rest of world. Excluding the U.S. market, retail sales were -5 percent, +2 percent cc. Total Anti-Infectives franchise sales amounted to $649 million (-8 percent, -3 percent cc), including finished dosage forms sold under the Sandoz name and Anti-Infectives sold to third parties for sale under their own name ($259 million, -9 percent, -5 percent cc).

Based on the company’s 2019 first half, full-year guidance was increased for Novartis. For full-year 2019, sales are projected to grow by mid to high-single digits (cc), core operating income is expected to increase by low double digits to the mid-teens (cc), and sales guidance rose for both business divisions. Innovative Medicines guidance was revised upwards, with anticipated growth in the mid to high-single digit. Sandoz was additionally revised upwards, broadly in line to low-single digit growth. The updated guidance includes the forecast assumption that no Gilenya generics enter the U.S. marketplace during 2019. According to Novartis, if mid-July 2019 exchange rates prevail for the remainder of the year, the currency impact for 2019 would be negative 3 percentage points on net sales and negative 4 percentage points on core operating income.

Novartis executives say 2019 is a landmark innovation year with the addition of new potential blockbusters to the product portfolio. First-half 2019 highlights included the Zolgensma gene therapy U.S. launch for the treatment of spinal muscular atrophy (SMA) in children under the age of 2 years, with robust clinical data presented at AAN showing efficacy in a broad spectrum of patients; Piqray (alpelisib) was introduced to the marketplace for treating advanced breast cancer with a PIK3CA mutation; and crizanlizumab (SEG101) for the treatment of sickle cell disease was submitted for approval in the United States and European Union with FDA priority review.

In addition, the Xiidra dry eye treatment was acquired, expanding the company’s leading presence in ophthalmic pharmaceuticals.
Novartis in June appointed Marie-France Tschudin as president of Novartis Pharmaceuticals. Tschudin is a member of the Executive Committee of Novartis and reports to CEO Vas Narasimhan.

Tschudin has more than 25 years of broad, multi-national experience in the pharma and biotech industry. She was most recently head of Novartis Pharmaceuticals, Region Europe, where Tschudin successfully grew the largest regional business within Novartis to more than $8 billion in 2018 sales. Tschudin also built a diverse leadership team and oversaw the preparations for Novartis’ potential blockbuster drug launches in Europe. Before joining Novartis, she spent 10 years at Celgene in various leadership and general management positions and led that company’s Hematology-Oncology business for Europe, Middle East, and Africa.

Zolgensma

Zolgensma (previously known as AVXS-101) was approved and launched in the United States in June 2019 for the treatment of pediatric patients less than 2 years of age with SMA with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Administered as a single, one-time intravenous infusion, Zolgensma is the first gene therapy approved by the FDA for treating all types of SMA, including those who are pre-symptomatic at diagnosis. Novartis says one-time treatment with Zolgensma offers an alternative to lifetime chronic therapy for patients with SMA.

Novartis is working closely with payers to offer pay-over-time options up to five years and outcomes-based agreements up to five years, as well as providing a patient program to support affordability and access. Zolgensma is undergoing regulatory review in Europe and Japan, with marketing approval expected during 2019.

The proprietary gene therapy is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression via sustained SMN protein expression with a single, one-time IV infusion. Zolgensma is the first approved therapeutic in a proprietary platform for the treatment of rare, monogenic diseases using gene therapy.

AveXis, a Novartis company, unveiled new interim data from the Phase III SPR1NT study in pre-symptomatic patients as well as interim data from the ongoing Phase III STR1VE clinical program for Zolgensma (onasemnogene abeparvovec-xioi) in September 2019. The data revealed positive outcomes, demonstrating age‑appropriate major milestone gain with pre‑symptomatic treatment and prolonged event-free survival in patients with SMA Type 1.

Updated results from the worldwide STR1VE study showed that Zolgensma has significant therapeutic benefit in prolonging event-free survival in SMA Type 1 patients versus natural history. AveXis says patients in the START long-term follow-up study (cohort 2), who are an average age of 4.2 years (oldest patient is 5 years), continue to achieve developmental milestones.

Before the announcement of these positive late-stage study results, FDA released a statement on Aug. 6 addressing data integrity issues with the Biologics License Application (BLA) for Zolgensma. Novartis issued the following statement on that same day: “First and foremost, we are fully confident in the safety, quality, and efficacy of Zolgensma. The FDA supports the continued marketing and use of Zolgensma for patients with SMA less than 2 years of age. We maintain that the totality of the evidence demonstrating the product’s effectiveness and its safety profile continue to provide compelling evidence supporting an overall favorable benefit-risk profile. We remain steadfast that this important treatment remain available to pediatric patients with SMA less than 2 years of age.

“On June 28th, AveXis voluntarily self-disclosed to the FDA and subsequently to other health authorities that some data previously submitted to the agency as part of our BLA package was inaccurate. AveXis had become aware of allegations of data manipulation in a specific animal testing procedure used in the development of the product. The assays in question were used for initial product testing and are not currently used for commercial product release. An investigation was immediately initiated to rapidly understand any implications and address the situation. Once we had interim conclusions from our investigations, we shared our findings with the FDA. As noted by the FDA, the data in question were a small portion of our overall submission and are limited to an older process no longer in use.”

Narasimhan made the following statement during the Novartis ESG Investor Event in London on Sept. 9: “We understand the FDA’s concerns and appreciate that the circumstances presented by a new gene therapy is something that should be taken into account with regard to timing of FDA notifications of data integrity investigations. Although we are confident that the actions we are taking will prevent data integrity issues from occurring in the future, going forward we are making a voluntary commitment to notify the FDA within five business days of receipt by our quality organization of any credible allegation related to data integrity impacting any pending application in the Novartis Group. We will take a similar approach in other jurisdictions, absent a specific local regulation to the contrary.”

Product Approvals/Launches and Pipeline Updates During 2019

One of Novartis’ key pipeline prospects is the fully human anti-CD20 monoclonal antibody ofatumumab (OMB157). Novartis reported during September Phase III ASCLEPIOS studies showing robust efficacy of ofatumumab in patients with relapsing multiple sclerosis. Clinical data from both trials demonstrated ofatumumab was superior to Sanofi’s blockbuster medicine Aubagio (teriflunomide) in patients with relapsing forms of MS. The ASCLEPIOS I and II studies are twin, identical design, flexible duration (up to 30 months), double-blind, randomized, multi-center Phase III trials testing the safety and efficacy of ofatumumab 20mg monthly subcutaneous injections versus Aubagio 14mg oral tablets taken once daily in adults with RMS.

Ofatumumab works by binding to the CD20 molecule on the B-cell surface and inducing potent B-cell lysis and depletion. If cleared for marketing, the new molecular entity will potentially become a treatment for a broad RMS population and the first B-cell therapy that is easy to start and manage in a monthly self-administered injection at home, according to Novartis.

As a leader reimagining rheumatology and immuno-dermatology, Novartis reported positive new data from the PREVENT study evaluating the efficacy and safety of Cosentyx in patients with nr-axSpA (non-radiographic axial spondyloarthritis). The ongoing Phase III trial met the primary endpoint of ASAS40 at Week 16, demonstrating a significant and clinically meaningful reduction in disease activity for patients treated with Cosentyx (secukinumab) compared to placebo. The clinical trial showed a favorable safety profile consistent with previous studies.

The company has filed an application with the EMA for nr-axSpA, which if approved would represent the fourth indication for Cosentyx. Axial spondyloarthritis is a spectrum of long-term inflammatory disease characterized by chronic inflammatory back pain. 52-week data from the PREVENT trial, to support a U.S. regulatory submission, are anticipated before year-end 2019.

Cosentyx is the first fully human biologic that directly inhibits interleukin-17A (IL-17A), which is a cornerstone cytokine involved in the inflammation and development of psoriatic arthritis (PsA), psoriasis (PsO), and ankylosing spondylitis (AS). The medication is backed by robust clinical evidence, including 5-year data across psoriasis, PsA and AS as well as data from real world evidence. Novartis says these data strengthen the unique position of Cosentyx as a rapid and long-lasting comprehensive treatment across axial spondyloarthritis, psoriatic arthritis and psoriatic disease, with more than 250,000 patients treated worldwide with Cosentyx since being launched during 2015.

During June, Novartis presented the first-of-its-kind MAXIMISE study, demonstrating efficacy and safety of a biologic in the management of axial manifestations of PsA. As the first IL-17A inhibitor, Cosentyx was introduced in China during May, based on clinical data that confirmed rapid response and high efficacy of Cosentyx in psoriasis patients.

Novartis management is hoping that the investigational lung cancer therapy capmatinib (INC280) will become the first targeted therapy approved to treat MET exon14 skipping-mutated non-small cell lung cancer, a particularly aggressive form of the disease. The company reported in September that the FDA granted Breakthrough Therapy Designation for capmatinib for patients with MET-mutated advanced NSCLC. A U.S. regulatory filing for the new drug candidate is anticipated for fourth-quarter 2019.

Recent research concludes that the cMET gene is an oncogenic driver, and capmatinib has been demonstrated to be a highly potent and selective MET inhibitor. The MET mutation is evident in an estimated 3 percent to 4 percent of all patients with NSCLC. These patients are generally older and frequently have a poor prognosis that can limit lung cancer treatment options.

Results from two clinical studies revealed in early September show that Entresto improved measures of heart structure and function in patients with heart failure with reduced ejection fraction (HFrEF). The results suggest that Entresto (sacubitril/valsartan) not only positively impacts a biomarker demonstrated to be associated with prognosis of clinical outcomes in HFrEF, but also that the effect is associated with significant improvement in the structural and functional changes – known as cardiac remodeling – that occur with this disease. The PROVE-HF study establishes a significant correlation between improvement in a widely used cardiac biomarker and positive changes in heart structure and the ability to pump blood in patients taking the medicine.

Entresto is indicated for treating patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction to reduce the risk of cardiovascular death and hospitalization for heart failure. Through the Entresto scientific program, Novartis is reimagining the standard of care for HFrEF patients and the use of the drug as a first-choice therapy in HFrEF and a therapy in other cardiovascular diseases.

The company undertook the largest global clinical program in the heart failure disease area across the pharma industry, called FortiHFy. The program consists of more than 40 active or planned clinical trials designed to generate an array of additional data on symptom reduction, efficacy, quality of life benefits and real-world evidence with Entresto, as well as to extend understanding of heart failure.

The Heart Failure Association of the European Society of Cardiology published a consensus paper during May supporting Entresto as a first-line treatment option for patients hospitalized with new-onset HFrEF or decompensated congestive HFrEF. The paper additionally simplified treatment initiation and supported the use of Entresto in every patient stabilized in hospital.

Kisqali (ribociclib) achieved statistically significant improvement in overall survival in the Phase III MONALEESA-3 clinical study, as reported by Novartis in July. This is the second Phase III study in which Kisqali combination therapy met the key secondary endpoint of overall survival at the pre-planned interim analysis. MONALEESA-3 evaluated efficacy and safety of Kisqali in combination with fulvestrant in postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in both the first-line and second-line settings.

Kisqali represents the CDK4/6 inhibitor with the largest body of first-line clinical trial evidence showing consistent and sustained efficacy versus endocrine therapy alone. The medicine is the only CDK4/6 inhibitor to achieve statistically significant overall survival in two Phase III studies with two distinct patient populations. Overall survival follow-up continues in the Phase III MONALEESA-2 study.

Approved for use in 75-plus countries, Kisqali was initially approved by U.S. regulators in March 2017 and by the European Commission during August 2017 as initial endocrine-based therapy for postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer in combination with an aromatase inhibitor based on findings from the pivotal MONALEESA-2 trial. Kisqali in combination with an aromatase inhibitor was cleared for marketing for treating pre-, peri- or postmenopausal women as initial endocrine based therapy, and also indicated for use in combination with fulvestrant as both first- or second-line therapy in postmenopausal women by the FDA during July 2018 and by the European Commission in December 2018. Regulatory submissions are under way with other health authorities around the globe.

Lucentis (ranibizumab) is on track to win approval in the European Union as the first pharmacological therapy for retinopathy of prematurity in vulnerable infants. On July 26, the company reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended approval of Lucentis for treating preterm infants with retinopathy of prematurity. The rare eye disease ROP is a leading cause of childhood blindness. The European Commission’s decision was expected by the end of October 2019.

The first anti-vascular endothelial cell growth factor (anti-VEGF) therapy licensed for ophthalmic use, Lucentis revolutionized the treatment of neovascular age-related macular degeneration and has helped reduce blindness due to nAMD by 50 percent in several parts of the world. More than a decade of innovation and six indications (nAMD, DME, BRVO, CRVO, mCNV and other CNV) later, Lucentis continues to preserve and resolve vision for patients, according to Novartis.

With 2018 global sales exceeding $3.7 billion, Lucentis is available in more than 110 countries. The medicine is backed by a portfolio of 251 sponsored clinical trials and extensive real-world experience. The Lucentis clinical development program has enrolled 130,000-plus patients worldwide across indications with 5.5 million patient-treatment years of exposure since the therapy’s U.S. launch during 2006. Joint developer Genentech holds the U.S. rights to Lucentis and Novartis maintains rights in the rest of the world.

Novartis’ top-selling medicine Gilenya received the multiple sclerosis product’s first approval in China during July. The Chinese National Medical Products Administration (NMPA) gave the green light to Gilenya for relapsing forms of multiple sclerosis for adults and children 10 years and older.

Novartis is dedicated to bringing innovation to China and to reimagining care for patients. Entresto was approved by the NMPA during 2017. Following the marketing clearance of Cosentyx in March 2019, Novartis says Gilenya is the next key company product approved from the list of urgently needed medicines in China. Multiple sclerosis is categorized as a rare disease in China with an estimated 30,000 MS patients in that country.

Mayzent (siponimod) was the recipient of FDA marketing clearance on March 26 for the treatment of relapsing forms of multiple sclerosis. The approved indication includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive MS in adults. Mayzent is the only FDA-approved oral therapy for active SPMS based on evidence from a pivotal prospective Phase III study (EXPAND) in a typical SPMS population. Mayzent is the first treatment specifically approved for patients with active SPMS in more than 15 years.

Research shows that up to 80 percent of patients with relapsing remitting MS will develop SPMS; Novartis says Mayzent addresses a critical unmet need for RRMS patients in transition and those with active SPMS who have transitioned. The U.S. approval is based on EXPAND – the largest controlled study of SPMS patients – demonstrating Mayzent significantly reduced the risk of disease progression, including impact on physical disability and cognitive decline. The next-generation, selective sphingosine 1-phosphate receptor modulator is approved across the MS spectrum for clinically isolated syndrome (CIS), RRMS and active SPMS, with most patients not requiring a first dose observation.

Mayzent selectively binds to S1P1 and S1P5 receptors. In relation to the S1P1 receptor, the drug prevents the lymphocytes from egressing the lymph nodes and as a consequence, from entering the CNS of patients with multiple sclerosis. This process results in the anti-inflammatory effects of Mayzent. The medicine additionally enters the central nervous system and directly binds to the S1P5 and S1P1 sub-receptors on specific cells in the CNS (oligodendrocytes and astrocytes) to promote re-myelination as well as prevent inflammation.

Biosimilar Progress During 2019

Sandoz entered into a worldwide commercialization pact in September with Polpharma Biologics for a proposed natalizumab biosimilar. The medicine is undergoing Phase III clinical development for treating relapsing-remitting multiple sclerosis (RRMS).

Through the deal, the European biopharmaceutical company Polpharma will maintain responsibilities for development, manufacturing and supply of the proposed biosimilar natalizumab. Sandoz will commercialize and distribute the medicine in all markets upon approval via an exclusive worldwide license.

Natalizumab represents the fifth proposed biosimilar in-licensed by Sandoz during 2018, underscoring a commitment to further grow the company’s pipeline via collaborations. The reference medicine natalizumab is a disease-modifying therapy marketed by Biogen as Tysabri that generated 2018 sales of $1.86 billion.

The U.S. District Court of New Jersey ruled against Sandoz in August in patent litigation concerning the Sandoz biosimilar Erelzi (etanercept-szzs) for the reference medicine Enbrel (etanercept). Sandoz is appealing the ruling to the U.S. Court of Appeals for the Federal Circuit, with parties agreeing to an expedited appeal.

Sandoz is the first biosimilar company to receive FDA marketing approval for a biosimilar etanercept. Erelzi was cleared for U.S. marketing during August 2016, but Sandoz has been unable to launch the arthritis product due to the patent litigation from Amgen. Enbrel is one of the top-selling drugs in the world, having generated more than $7 billion in 2018 sales.

The first patient was enrolled during July in ROSALIA, an integrated clinical study for Sandoz’s potential biosimilar denosumab. The Phase I/III study intends to confirm that the biosimilar matches the reference medicine in terms of pharmacokinetics, efficacy, safety, and immunogenicity in patients with postmenopausal osteoporosis.

Denosumab is marketed around the globe by Amgen and Daiichi Sankyo as Prolia/Pralia and produced 2018 sales exceeding $2.5 billion. The product is indicated for treating various conditions including osteoporosis in postmenopausal women, increased risk of fractures in men, treatment-induced bone loss, to prevent bone complications in cancer that has spread to the bone, and giant cell tumor of the bone. The Sandoz study is being conducted in osteoporosis as this is an adequately sensitive indication and representative of many patients who are treated with the medicine, according to the company.

During June, Hyrimoz (Sandoz biosimilar adalimumab) Phase III ADMYRA trial data presented at the Annual European Congress of Rheumatology confirmed switching from the reference biologic had no impact on safety or efficacy in patients with moderate-to-severe rheumatoid arthritis. The data reinforces a review summarizing 90+ publications, that switching from the reference biologic to biosimilars does not impact safety, efficacy or immunogenicity. Adalimumab is the active ingredient in the world’s best-selling prescription medicine Humira, which is marketed globally by AbbVie. Hyrimoz during 2018 was approved for use and launched in the EU and cleared for marketing by FDA.