Pfizer Inc. today announced that the REFLECTIONS B7391003 study — a comparative, confirmatory safety and efficacy study of PF-06439535 versus Avastin (bevacizumab) — met its primary objective. PF-06439535 is being developed by Pfizer as a potential biosimilar to Avastin.
Celltrion Inc. and Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration accepted for review the Biologics License Application for CT-P10, a proposed Monoclonal Antibody (mAb) biosimilar to Rituxan (rituximab), which is used to treat patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.
Boehringer Ingelheim announced results from the pivotal Phase III VOLTAIRE-RA1 study, confirming that its adalimumab biosimilar candidate BI 695501 and Humira have similar efficacy, safety and immunogenicity in patients with moderately-to-severely active rheumatoid arthritis.
R&D success and M&A activity loom as large swing factors for the bio sector in 2017 with the regulatory arena potentially at its most amenable for years.
The U.S. FDA Oncologic Drugs Advisory Committee recommended approval of Pfizer’s proposed epoetin alfa biosimilar across all indications.
AbbVie’s biologic therapy Humira for autoimmune diseases was the worldwide prescription-drug sales leader in 2015 for the fourth consecutive calendar term.
IMS analysis revealed that lower-cost copies of complex biotechnology drugs could save the United States and Europe’s five top markets as much as €98 billion ($110 billion) by 2020.
Or, why 2016 might look a little different than 2015 for pharmaceutical marketers.
The pharma industry’s R&D concentration has been shifting towards specialty therapy areas as research and development returns decline for some leaders.
Executives from the 2015 and 2014 Manny Award winners and finalists share their views on a variety of industry-related topics.