On September 30, 2021, the European Medicines Agency (EMA) released a report entitled “Tailored Scientific Advice for Biosimilar Development,” describing results from its pilot program in which biosimilar applicants were invited to solicit scientific advice from regulatory authorities. In the European Economic Area (EEA), biosimilar approval requires applicants to submit…
The Korea Herald has reported that Celltrion Inc., a South Korean biopharmaceutical firm, is seeking approval from the European Medicines Agency (EMA) for the sale of CT-P16, Celltrion’s anticancer biosimilar candidate. CT-P16 references Avastin (Bevacizumab), which is indicated for the treatment of various types of cancers, including colorectal, lung, and kidney…
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Alvotech‘s high-concentration AVT02 (100 mg/mL), a proposed biosimilar to Humira® (adalimumab). Humira® is approved to treat certain inflammatory conditions. Róbert Wessman, Founder and Chairman of Alvotech, announced, “We are delighted by the CHMP’s…
In honor of Women’s History Month, Big Molecule Watch continues to highlight the work of women who have contributed to the advancement of biologics and biosimilars. One such individual is Emer Cooke, who is the first woman to occupy the role of Executive Director of EMA and to lead that…
At its January meeting last week, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approval for two biosimilar bevacizumab medicines, Alymsys and Oyavas. Mabxience Research SL’s Alymsys and STADA Arzneimittel AG’s Oyavas both received positive opinions for the treatment of carcinoma of the colon or rectum, breast cancer, non-small…
Last week, Shanghai Henlius Biotech announced that China’s National Medical Products Administration has approved its adalimumab biosimilar candidate for the treatment of rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis. Henlius stated that this is its third biosimilar approval in China, following approval of its rituximab and trastuzumab biosimilar products. Celltrion…
Samsung Bioepis and Biogen issued a press release on November 18 announcing that the U.S. Food and Drug Administration has accepted for review their Biologics License Application for SB11, a proposed biosimilar of Lucentis® (ranibizumab). Ranibizumab is an anti-VEGF (vascular endothelial growth factor) therapy used to treat retinal vascular disorders,…
Emer Cooke, with 30 years’ experience in international regulatory affairs, took up her position this morning as Executive Director of EMA with a renewable five-year mandate. Previously, Ms. Cooke worked for the pharmaceutical unit of the European Commission and EMA and was the Director responsible for all medical product-related regulatory…
Alvotech and Cipla Medpro, a wholly owned subsidiary of Cipla Limited, recently announced an exclusive partnership “to bring key biosimilars to patients in markets such as South Africa.” The biosimilars portfolio will include two oncology drugs and three drugs for treating autoimmune diseases. The press release reports that under the…
Last week, the EMA issued a positive opinion for Orphan Drug Designation (“ODD”) to Prestige BioPharma’s PBP1510, a first-in-class anti-PAUF monoclonal antibody. PAUF is found in a majority of pancreatic cancers and plays an important role in disease progression; PBP1510 received ODD for the treatment of pancreatic cancer, for which…