Amgen: Transforming For The Future

,

 

Amgen has focused the company’s business and operating model through significant transformation and process improvement efforts to produce innovative medicines while generating satisfactory investor returns.

 

amgen-logo

 

Amgen Inc.

One Amgen Center Drive
Thousand Oaks, CA
91320-1799
Telephone: 805-447-1000
Website: amgen.com

 

 

 

 

Best-Selling Products

Product 2015 Sales 2014 Sales
Enbrel

$5,364

$4,688

Neulasta

$4,715

$4,596

Aranesp

$1,951

$1,930

Epogen

$1,856

$2,031

Sensipar/Mimpara

 

$1,415

 

$1,158
XGEVA

$1,405

$1,221

Prolia

$1,312

$1,030

Neupogen $1,049 $1,159
Vectibix $549 $505
Nplate

$525

$469

Kyprolis

$512

$331

All sales are in millions of dollars.

 

 

 

Financial Performance

  2015 2014
Revenue

$21,662

$20,063

Net income

$6,939

$5,158

Diluted EPS

$9.06

$6.70

R&D expense 

$4,070

$4,297

  1H16 1H15
Revenue

$11,215

$10,403

Net income

$3,770

$3,276

Diluted EPS 

$4.97

$4.26

R&D expense

$1,772

$1,858

In millions of dollars, except EPS

 

 

 

2015 was a record-setting year for Amgen in terms of revenue and earnings. Revenue increased 8 percent to $21.66 billion and the company reported 19 percent adjusted earnings per share growth. Also during the year, an unprecedented six innovative new product offerings reached the marketplace. These are some of the benefits of Amgen’s ongoing transformation efforts that were launched company-wide three years ago, and better-than-expected first-half results show that more records will be set by the end of 2016. Amgen is demonstrating clear progress toward the company’s 2018 commitments to investors and solidly advancing management’s strategy for long-term growth.

Among the six new product offerings introduced in 2015, four are in oncology and two are in cardiovascular disease. According to company leadership, all of these treatments demonstrated positive initial reception by physicians, patients and payers. Meanwhile, Amgen has a variety of promising innovative pipeline opportunities making progress in focused therapeutic areas.

Amgen is concentrated on six therapeutic fields: oncology/hematology, cardiovascular disease, inflammation, bone health, nephrology and neuroscience. The company systematically allocates resources across the best of the internal and external programs available to Amgen within those six therapeutic areas. This process generates a productive balance of internal development and external programs and collaborations, the outcome of which is reflected in Amgen’s existing product portfolio.

The company’s strategy is to advance innovative medicines and a portfolio of biosimilar medicines to address serious illness; expand geographic reach; transition to next-generation manufacturing; improve its biologic drug delivery systems; and allocate capital to shareholders while investing substantially in the corporation’s business for long-term growth.

 

2016 Performance & Outlook

Amgen revenue for first-half 2016 came in at $11.22 billion, which was eight percent higher than the amount from the one-year-earlier period. The growth was driven by year-over-year increased sales from Enbrel, Prolia, Kyprolis and XGEVA. Net income during the first six months of 2016 was reported at $3.77 billion, up 15 percent. Diluted EPS totaled $4.97, a 17 percent improvement over the 2015 first half. Net income and diluted EPS growth was driven by increases in revenues and operating margins.

Based on the first-half performance, full-year 2016 total revenue is projected to land in the range of $22.5 billion to $22.8 billion; previously, management expected a revenue range of $22.2 billion to $22.6 billion. On a GAAP basis, 2016 EPS is estimated in the range of $9.55 to $9.90 compared to the former guidance projection of $9.34 to $9.74. EPS on a non-GAAP basis is on track for $11.10 to $11.40, versus a prior expectation of $10.85 to $11.20.

Enbrel remains Amgen’s top-selling product, with first-half 2016 sales growing 16 percent year-over-year to $2.87 billion. The improvement was driven primarily by an increase in net selling price, partially offset by a decrease in units due to competition.

Containing etanercept, Enbrel is a fusion protein that inhibits tumor necrosis factor. Launched during 1998, Enbrel is approved for moderately to severely active rheumatoid arthritis, chronic moderate-to-severe plaque psoriasis patients who are candidates for systemic therapy or phototherapy, and active psoriatic arthritis. Pfizer holds the rights to market and sell the biologic outside the United States and Canada.

Amgen’s No. 2 seller is Neulasta, a pegylated protein based on the filgrastim molecule, primarily in the United States and Europe. Introduced to the market in 2002, Neulasta is used primarily in the indication to help reduce the chance of infection due to a low white blood cell count, in people with certain types of cancer (non-myeloid) who receive anti-cancer medicines (chemotherapy) that can cause fever and a low blood cell count.

Neulasta sales increased 2 percent to $2.33 billion during the first six months of 2016. The growth in worldwide sales was driven primarily by an increase in U.S. net selling price, offset partially by a decrease in unit demand. As of June 30, the Neulasta Onpro kit – which was launched in March 2015 – accounted for 40 percent of Amgen’s U.S. Neulasta business that totaled $1.96 billion in the 2016 first half.

Aranesp (darbepoetin alfa) is the other Amgen product that generated blockbuster sales in the first half of 2016, recording $1.04 billion on 8 percent year-over-year growth. The product’s worldwide sales growth was driven primarily by higher unit demand – including a shift by some U.S. dialysis customers from Epogen to Aranesp – offset partially by a decline in net selling price and unfavorable inventory changes. Amgen says supplementary protection certificates issued by certain countries – including France, Germany, Italy, Spain and the U.K. – relating to the company’s European patent for darbepoetin alfa expired during June 2016.

Launched during 2001, Aranesp is marketed by Amgen primarily in Europe and the United States. Aranesp is indicated for treating anemia caused by chronic kidney disease (in both patients on dialysis and patients not on dialysis). The drug is additionally indicated for treating anemia due to concomitant myelosuppressive chemotherapy in patients with non-myeloid malignancies, and when chemotherapy will be used for at least two months after starting Aranesp.

Prolia (denosumab) worldwide sales improved from $612 million in first-half 2015 to $793 million during the first six months of 2016. Growth of 32 percent in the United States and 26 percent in the rest of the world (ROW) was driven primarily by higher unit demand.

prolia-0311

Available in more than 80 countries, Prolia is the first approved therapy that specifically targets RANK Ligand, an essential regulator of bone-removing cells (osteoclasts). Prolia was introduced to the U.S. and European markets during 2010. In the United States, the product is used primarily for treating postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In Europe, Prolia is used primarily for treating osteoporosis in postmenopausal women at increased risk of fractures.

Double-digit U.S. (14 percent) and ROW (11 percent) growth for XGEVA – also containing the active ingredient denosumab – was paced mainly by higher unit demand and net selling price, as global first-half 2016 sales reached $759 million. Though composed of the same main chemical as Prolia, XGEVA is approved for different indications, patient populations, doses and frequencies of administration.

xgeva-0311

Introduced in the United States during 2010, XGEVA is approved for the prevention of skeletal-related events (SREs) (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in patients with bone metastases from solid tumors. The medicine was launched in Europe during 2011 for the prevention of SREs in adults with bone metastases from solid tumors.

For Sensipar/Mimpara (cinacalcet), 12 percent worldwide growth to $756 million in the 2016 first half was also driven primarily by an increase in net selling price and higher unit demand. The result, however, was offset partially by unfavorable changes in wholesaler and, based on prescription data, end-user inventories.

Amgen markets cinacalcet as Sensipar primarily in the United States and as Mimpara mainly in Europe. The product was launched in 2004 for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease (CKD) on dialysis.

Epogen (epoetin alfa) first-half sales in the United States experienced a steep drop-off year-over-year, falling 38 percent to $631 million. The product’s downturn in performance was primarily attributed to a decrease in units resulting from competition and, to a lesser extent, a shift by some U.S. dialysis patients to Aranesp.

Launched in 1989, Amgen markets Epogen in the United States to treat a lower-than-normal amount of red blood cells (anemia) caused by CKD in patients on dialysis to lessen the need for red blood cell transfusions. The majority of the company’s Epogen sales are to two large dialysis providers.

In the first half of 2016, global sales for Neupogen amounted to $409 million, down 22 percent in the United States ($291 million) and 9 percent in the rest of the world ($118 million). The decline in worldwide Neupogen (filgrastim)sales was driven primarily by lower unit demand in the United States because of the impact of short-acting competition. According to Amgen, U.S. competition has intensified and will continue to have a material adverse impact on Neupogen sales. On Sept. 3, 2015, Sandoz announced it had launched a biosimilar version of Neupogen in the United States under the trade name Zarxio. On Feb. 17 of the same year, Apotex announced that the FDA had accepted its application for filing under the abbreviated pathway for its proposed biosimilar version of Neupogen.

Amgen markets Neupogen primarily in the United States, Canada and Europe. The recombinant-methionyl human granulocyte colony-stimulating factor (G-CSF) was introduced to the marketplace during 1991. Neupogen helps reduce the chance of infection due to a low white blood cell count in people with certain forms of cancer (non-myeloid) who receive anti-cancer medicines (chemotherapy) that can cause fever and a low blood cell count.

Other products marketed by Amgen include Vectibix (panitumumab) for wild-type KRAS metastatic colorectal cancer; Nplate (romiplostim) for treating low blood platelet counts in adults with chronic immune thrombocytopenia; the multiple myeloma drug Kyprolis (carfilzomib); Blincyto (blinatumomab) for acute lymphoblastic leukemia; the PCSK9 inhibitor Repatha (evolocumab) for additional lowering of low-density lipoprotein cholesterol; Corlanor (ivabradine) for reducing the risk of hospitalization due to worsening heart failure; and Imlygic (talimogene laherparepvec), the first FDA-approved oncolytic viral therapy designed to replicate in cancer cells leading to oncolysis.

 

Product Approvals/Launches & Pipeline Updates In 2016

Amgen takes a modailty-independent approach to research and development with a focus on biologics, according to management. The company’s discovery research programs may therefore yield targets that result in the development of human therapeutics delivered as large molecules, small molecules, or other combination or new modalities.

Amgen’s R&D expenses came to $4.07 billion during 2015 and $1.77 billion for the first six months of 2016, with both totals representing decreases compared to their one-year-earlier counterparts. The decline in first-half 2016 R&D was driven by savings resulting from transformation and process improvement efforts, a portion of which were reinvested for the long-term benefit of Amgen, as well as by lower spending required to support certain later-stage clinical programs. Costs associated with the company’s later-stage clinical programs support declined by $566 million in first-half 2016, offset by increased costs in marketed products support of $487 million.

Near the end of September 2016, Amgen revealed top-line results from the Phase 3 CLARION trial for Kyprolis in newly diagnosed multiple myeloma patients. The study evaluated an investigational regimen of Kyprolis, melphalan and prednisone (KMP) versus Velcade (bortezomib), melphalan and prednisone (VMP) for 54 weeks in patients with newly diagnosed multiple myeloma who were ineligible for hematopoietic stem-cell transplant. Amgen reported that the study did not meet the primary endpoint of superiority in progression-free survival (PFS).

Kyprolis is FDA-approved for the following: in combination with dexamethasone or with lenalidomide plus dexamethasone for treating patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy; and as a single agent for treating patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. The drug is additionally marketed in Argentina, Israel, Kuwait, Mexico, Thailand, Colombia, Korea, Canada, Switzerland, Russia, Brazil and the European Union. Other regulatory applications for Kyprolis are under way and have been filed with health authorities around the globe.

In January 2016, Kyprolis received the green light from FDA for the supplemental New Drug Application (sNDA) of Kyprolis for Injection in combination with dexamethasone or with lenalidomide plus dexamethasone for treating patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. U.S. regulators additionally approved Kyprolis as a single agent for treating patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. This FDA decision converted to full marketing clearance the initial accelerated approval Kyprolis received during July 2012 as a single agent.

The European Commission approved the extended indication for Kyprolis of treating relapsed multiple myeloma patients, as announced by Amgen in early July. The extended indication represented the second approval for Kyprolis by the EC in less than one year.

Amgen during June reported results from a post-hoc analysis of the pivotal Phase 3 ASPIRE trial that highlighted the benefit of continued treatment with Kyprolis in combination with lenalidomide and dexamethasone (KRd) in patients with relapsed multiple myeloma. Separate sub-analyses of the Phase 3 ENDEAVOR trial additionally confirmed efficacy and depth of response benefits of Kyprolis plus dexamethasone (Kd).

In other June news for Kyprolis, data from ASPIRE demonstrated that the drug in combination with KRd improved PFS and overall response rate (ORR) versus lenalidomide and dexamethasone (Rd) alone in patients with relapsed multiple myeloma with early disease progression after initial therapy or transplant.

Proteasomes play a significant role in cell function and growth by breaking down proteins that are damaged or no longer needed. Kyprolis has been demonstrated to block proteasomes, resulting in an excessive build-up of proteins within cells. In certain cells, the medicine can cause cell death, especially in myeloma cells because they are more likely to contain a higher amount of abnormal proteins.

U.S. regulators accepted for review the Biologics License Application (BLA) for romosozumab, as detailed by Amgen and UCB during September. The investigational monoclonal antibody is intended for treating osteoporosis in postmenopausal women at increased risk of fracture. The drug compound works by binding and inhibiting the activity of the protein sclerostin, which is a protein naturally occurring in the bone, thereby increasing bone formation and decreasing bone resorption.

The BLA was filed with FDA on July 19, 2016, and is based on data from the pivotal Phase 3 placebo-controlled FRActure trial in postmenopausal woMen with ostEoporosis (FRAME) consisting of 7,200 patients. A Prescription Drug User Fee Act (PDUFA) target action date of July 19, 2017, has been set by FDA for romosozumab.

As of press time, romosozumab had not been approved by any regulatory health body for osteoporosis treatment. The experimental bone-forming monoclonal agent is designed to work by inhibiting the activity of the protein sclerostin. Romosozumab has a dual effect on bone by increasing bone formation and decreasing bone breakdown. The drug candidate is being evaluated for its potential to reduce the risk of fractures in an extensive worldwide Phase 3 program. The program includes two large fracture studies comparing romosozumab to either placebo or active comparator in more than 10,000 postmenopausal women with osteoporosis. Amgen and UCB are jointly developing romosozumab.

Those two companies in April reported detailed Phase 3 results with romosozumab showing a statistically significant increase in hip bone mineral density (BMD) and strength compared with teriparatide in postmenopausal women with osteoporosis transitioning from bisphosphonate treatment. The data came from the randomized, open-label, international, multi-center STRUCTURE study (STudy evaluating effect of RomosozUmab Compared with Teriparatide in postmenopaUsal women with osteoporosis at high risk for fracture pReviously treated with bisphosphonatE therapy).

Amgen and UCB are also investigating romosozumab in men with osteoporosis through the pivotal Phase 3 placeBo-contRolled study evaluatIng the efficacy anD safety of romosozumab in treatinG mEn with osteoporosis (BRIDGE). The clinical trial met the primary endpoint, showing a statistically significant increase in BMD at the lumbar spine (as assessed by dual energy x-ray absorptiometry) in men with osteoporosis treated with romosozumab versus placebo at 12 months.

Amgen revealed positive top-line results from its Phase 3 GLAGOV imaging clinical trial of Repatha in September. Having met its primary and secondary endpoints, GLAGOV is a large serial coronary intravascular imaging study designed to test whether treatment with the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor Repatha modifies atherosclerotic plaque build-up in the coronary arteries of patients already treated with optimized statin therapy. This was the first study to show that lowering LDL cholesterol with a PCSK9 inhibitor impacts underlying atherosclerotic disease on top of optimized statin therapy. Consisting of 950 patients, GLAGOV stands for GLobal Assessment of Plaque ReGression with a PCSK9 AntibOdy as Measured by IntraVascular Ultrasound.

Repatha also consistently reduced LDL-C in patients across cardiovascular risk subgroups or with familial hypercholesterolemia (FH), according to Phase 3 results revealed by Amgen in August.

The human monoclonal antibody Repatha inhibits PCSK9. Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein receptor (LDLR). This process prevents PCSK9-mediated LDLR degradation and allows LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the amount of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.

Repatha is approved in 40-plus countries, including the United States, Japan, Canada and all 28 EU member countries. Repatha during January became the first PCSK9 inhibitor to be approved in Japan as a treatment of high cholesterol. Applications in other nations are pending.

In July, FDA approved the Repatha Pushtronex system (on-body infusor with prefilled cartridge). A monthly single-dose administration option, the Pushtronex system is a hands-free device designed to provide 420 mg of Repatha in one dose.

In other clinical results for Repatha, data was reported in April from the Phase 3 GAUSS-3 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3) study. The trial demonstrated that in patients with reproducible statin intolerance due to muscle-related side effects (MRSE), the use of Repatha compared to ezetimibe resulted in a significantly greater reduction in LDL-C after 24 weeks.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) during September adopted a positive opinion for the Marketing Authorization of Parsabiv (etelcalcetide). CHMP recommended approval for treating secondary hyperparathyroidism (sHPT) in adult patients with CKD on hemodialysis. If cleared for marketing, Parsabiv would be the first calcimimetic agent that can be administered intravenously by a healthcare provider three times a week after a hemodialysis session.

Mimpara was the first oral calcimimetic agent approved by the EMA for treating sHPT in patients with CKD on dialysis. A novel calcimimetic agent, Parsabiv is undergoing clinical development for treating sHPT in adult CKD patients on hemodialysis that is administered intravenously at the end of the hemodialysis session. A calcimimetic is a drug that mimics the action of calcium, doing so by activating the calcium-sensing receptors on the parathyroid gland. Parsabiv binds to and activates the calcium-sensing receptor on the parathyroid gland, and PTH levels decrease as a result.

Parsabiv has not fared as well with U.S. drug regulators. In August, the Food and Drug Administration issued a Complete Response Letter for the New Drug Application for Parsabiv for treating sHPT in adult patients with CKD on hemodialysis. Amgen is reviewing the letter and expected a post-action meeting with FDA by year-end 2016 to discuss the Complete Response, which does not impact the company’s regulatory filings in other regions.

Blincyto was granted FDA accelerated approval for use in pediatric patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia, as announced on Sept. 1. The anti-CD19 x anti-CD3 (BiTE) bispecific antibody construct was initially FDA-approved in December 2014 to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia, an uncommon form of ALL. Blincyto has been granted breakthrough therapy, priority review and orphan drug designations by U.S. regulators. During November 2015, the immunotherapy was granted conditional marketing authorization in the European Union for treating adults with Ph- relapsed or refractory B-cell precursor ALL.

Data from the Phase 3 TOWER trial demonstrated that Blincyto improved overall survival in patients with B-cell precursor ALL, according to Amgen in a June press statement. Blincyto showed an almost two-fold increase in median overall survival versus standard of care. This is the first immunotherapy to show overall survival benefit compared to standard of care in the difficult-to-treat patient population.

The landmark deCODE genetics study pointed to a new mechanism that affects cholesterol levels and the risk of heart disease, according to analysis released in May. deCODE – a wholly owned subsidiary of Amgen and a worldwide leader in analyzing and understanding the human genome – announced the discovery of a rare variation in the sequence of the human genome that confers on carriers a substantial reduction in levels of non-HDL cholesterol, the best measure of the type of cholesterol that causes the formation of plaques in the arteries that are at the root of most heart disease. However, the most remarkable quality of this variation is that it confers greater protection against coronary heart disease than can easily be accounted for by reducing cholesterol alone.

FDA accepted for review Amgen’s supplemental Biologics License Application (sBLA) for the expanded use of Enbrel as a treatment for pediatric patients with chronic severe plaque psoriasis, as reported in March. If approved, Enbrel would be the first systemic drug to be marketed in the United States to treat chronic severe plaque psoriasis in pediatric patients. U.S. regulators set a PDUFA target action date of Nov. 5, 2016, for the Enbrel sBLA filing.

 

Deals & Collaborations In 2016

Amgen acquired worldwide development and commercial rights from Boehringer Ingelheim – as announced on Sept. 1 – for BI 836909 (the new product code is AMG 420), a bispecific T cell engager that targets B-cell maturation antigen. BCMA is a potential target for multiple myeloma. BI 836909/AMG 420 is undergoing Phase 1 studies. The drug compound was originally licensed to Boehringer Ingelheim by Micromet before the company was purchased by Amgen during 2012.

BiTE antibody constructs are a type of immunotherapy being studied for fighting cancer by helping the body’s immune system to detect and target malignant cells. The modified antibodies are designed to engage two different targets simultaneously, thereby juxtaposing T cells (a form of white blood cell capable of killing other cells perceived as threats) to cancer cells. BiTE antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins and trigger the cancer cell to die, known as apoptosis). BiTE antibody constructs are being investigated for their potential to treat a various cancers.

On the same day that the BI deal was announced, Amgen and Servier agreed to advance their cardiovascular collaboration. Servier decided to exercise its option to commercialize omecamtiv mecarbil in chronic heart failure in Europe, as well in as the Commonwealth of Independent States, including Russia, which were added to the collaboration. The companies additionally announced the omecamtiv mecarbil Phase 3 program would advance forward in collaboration with Cytokinetics. The novel cardiac myosin activator is being developed by Amgen in collaboration with Cytokinetics and Servier.

A global deal for the development and commercialization of Advaxis’ ADXS-NEO was announced by Amgen in early August. Amgen received exclusive global rights to develop and commercialize ADXS-NEO. The novel, preclinical investigational cancer immunotherapy treatment is designed to activate a patient’s immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient’s tumor. This collaboration unites Amgen’s development expertise in immuno-oncology with Advaxis’ MINE (My Immunotherapy Neo-Epitopes) program, which is uniquely positioned to develop a customized approach to treating cancer.

 

Biosimilar Progress In 2016

Amgen’s robust pipeline of biosimilars consists of nine programs. Amgen received the company’s first regulatory approval for a biosimilar product during September 2016. Amjevita (adalimumab-atto) was cleared for marketing across all eligible indications of the reference product Humira (adalimumab), an anti-TNF-α monoclonal antibody that was the world’s top-selling prescription medicine in 2015. Amjevita is the first adalimumab biosimilar to gain U.S. approval. The biosimilar was approved for treating seven inflammatory diseases: moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe chronic plaque psoriasis, adult moderate-to-severe Crohn’s disease and moderate-to-severe ulcerative colitis.

Amgen’s biosimilar adalimumab is undergoing review by the European Medicines Agency, following a regulatory application filed during December 2015.

Amgen and Allergan during July reported results from a Phase 3 trial studying the efficacy and safety of ABP 980 compared with trastuzumab in patients with human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer. The data ruled out inferiority compared to trastuzumab, but could not rule out superiority based on its primary efficacy endpoint of the difference of the percentage of patients with a pathologic complete response (pCR).

ABP 980 is being developed as a biosimilar to trastuzumab, which is a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody that targets HER2. Trastuzumab is approved under the brand name Herceptin by Roche and Genentech in many countries for treating HER2-positive early breast cancer, metastatic breast cancer and metastatic gastric cancer.

ABP 980 is one of four oncology biosimilars that Amgen and Allergan are collaborating on in terms of development and commercialization. Allergan is additionally developing biosimilars on its own.

Amgen also is collaborating with Daiichi Sankyo in the biosimilar arena. The two companies struck a pact in July to commercialize nine biosimilars in Japan. The transaction involves several biosimilars in late-stage development, including versions of adalimumab, bevacizumab and trastuzumab. The cancer medicine bevacizumab is sold by Roche/Genentech under the trade name Avastin.

Amgen is responsible for the development and manufacturing of the biosimilars. Daiichi Sankyo will file for marketing approval and is responsible for distribution and commercialization in Japan, while Amgen has a limited right to jointly promote the products.