Center for Biosimilars®
WEBFind out the latest news on biosimilars, including approvals, market access, pricing, and research. Learn from experts and stakeholders on biosimilar trends, challenges, and opportunities.
FDA Approves Celltrion and Teva's Trastuzumab Biosimilar, Herzuma
WEBDec 15, 2018 · The FDA has approved Celltrion and Teva’s Herzuma (trastuzumab-pkrb), a biosimilar trastuzumab referencing Herceptin, for the treatment of HER2-positive breast cancer. “Biosimilars are of growing importance to the oncology community and the approval of Herzuma may provide more patients access to this important therapy,” said Woosung Kee, CEO of Celltrion, in a statement announcing the ...
FDA Approves Coherus’ Cimerli as Interchangeable Biosimilar to …
WEBAug 3, 2022 · Cimerli is a ranibizumab biosimilar developed by Coherus that can be substituted for the reference product Lucentis without prescribing clinician intervention. It is indicated for 5 retinal conditions and has 12 months’ exclusivity on interchangeability.
The Approval Process for Biosimilars
WEBOct 10, 2018 · The drug is tested in many different ways. That’s a reference biologic. When you get to the biosimilar, the triangle is reversed. That reference biologic has done all of the work at the top of the triangle. The biosimilar is really showing that it’s biologically similar. So the triangle is reversed. You need to show that it’s clinically ...
Roman Drai Discusses Geropharm's Biosimilar Pursuits
WEBMay 12, 2020. Video. Roman Drai, MD, PhD, deputy director and head of clinical operations at Geropharm, discussed Geropharm’s budding biosimilar pipeline and the company’s international pursuits during the World Biosimilar Congress USA 2020 at the Festival of Biologics USA in San Diego, California. Roman Drai, MD, PhD is the deputy director ...
FDA Approves Pfizer's Rituximab Biosimilar, Ruxience
WEBJul 23, 2019 · Ruxience is a biosimilar of Rituxan, approved for certain indications of non-Hodgkin lymphoma, chronic lymphocytic leukemia, and autoimmune diseases. The biosimilar was shown to have similar efficacy, safety, and …
Russian Drug Maker Gains World's First Approval for Biosimilar …
WEBApr 11, 2019 · While Generium is the first to gain approval for its biosimilar, it is by no means the only Russian drug developer with an interest in eculizumab; Biocad recently announced that it has begun clinical studies for its own biosimilar eculizumab candidate referencing Soliris. Biocon’s study of the eculizumab biosimilar in patients with PNH ...
FDA Releases Guidance on Biologic, Biosimilar, and …
WEBMar 7, 2019 · The FDA no longer intends to retroactively give approved biologics 4-letter suffixes devoid of meaning, according to an updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars. However, the new guidance explains that the agency will continue to assign suffixes to newly approved innovator biologics ...
Prestige BioPharma’s Manufacturing Facility for Trastuzumab …
WEBFeb 23, 2022 · According to the statement, Prestige Biopharma’s research pipeline includes biosimilars and first-in-class therapies, including biosimilars referencing Avastin and Humira. “EU-GMP certification of our manufacturing arm in Korea demonstrated our global standard biomanufacturing facility and system that are applied to all of our products ...
Eye on Pharma: NeuClone Developing Denosumab Biosimilar
WEBJan 8, 2018 · Australian biosimilar developer NeuClone has announced that it is developing a proposed biosimilar denosumab (referenced on Amgen’s Prolia, Xgeva). Denosumab, a RANK ligand inhibitor, is used in the treatment of osteoporosis, as well as treatment-induced bone loss, among other indications. The …