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RSS FeedPosted by Michael Wonder on 24 Jul 2019
FDA approves Pfizer's biosimilar Ruxience (rituximab-pvvr), for certain cancers and auto-immune conditions
23 July 2019 - Pfizer today announced the United States FDA has approved Ruxience (rituximab-pvvr), a biosimilar to Rituxan (rituximab), ...
Posted by Michael Wonder on 24 Jul 2019
Merck's biosimilar to AbbVie's Humira wins FDA approval
24 July 2019 - The U.S. FDA approved Merck & Co Inc’s biosimilar to AbbVie's blockbuster rheumatoid arthritis treatment Humira, ...
Posted by Michael Wonder on 20 Jul 2019
Amgen and Allergan's Mvasi (bevacizumab-awwb) and Kanjinti (trastuzumab-anns) now available in the United States
19 July 2019 - First biosimilar Avastin and Herceptin products to launch in the United States. ...
Posted by Michael Wonder on 11 Jul 2019
Biosimilars continue to exhibit market failure
11 July 2019 - From their inception, biosimilars in the U.S. have faced headwinds. ...
Posted by Michael Wonder on 29 Jun 2019
Pfizer receives U.S. FDA approval for its first biosimilar, Zirabev (bevacizumab-bvzr)
28 June 2019 - Pfizer today announced the U.S. FDA has approved Zirabev (bevacizumab-bvzr), a biosimilar to Avastin (bevacizumab), for the ...
Posted by Michael Wonder on 24 Jun 2019
How big pharma suppresses ‘biosimilars’
23 June 2019 - Deals with insurers and pharmacy benefit managers at patient and taxpayer expense. ...
Posted by Michael Wonder on 14 Jun 2019
Ensuring innovation and competition for biologics leads to more timely products for patients
13 June 2019 - Today, the FDA approved the agency’s 20th biosimilar product, Kanjinti (trastuzumab-anns), for the treatment of patients with ...
Posted by Michael Wonder on 13 Jun 2019
Amgen wins FDA approval for Kanjinti injection for treatment of breast cancer, gastro-esophageal junction adenocarcinoma
13 June 2019 - U.S. FDA says Kanjinti (trastuzumab-anns) is biosimilar to Herceptin (trastuzumab). ...
Posted by Michael Wonder on 11 Jun 2019
Should the FDA disclose new filings for drugs, biologics and biosimilars?
11 June 2019 - In 2010, the FDA issued draft recommendations on increasing the transparency of the FDA’s processes and ...
Posted by Michael Wonder on 21 May 2019
FDA replaces withdrawn biosimilar guidance with new one on quality-related considerations
21 May 2019 - A week after finalizing guidance on developing interchangeable biosimilars, the US FDA has drafted guidance for ...
Posted by Michael Wonder on 10 May 2019
Statement from Acting FDA Commissioner on policy advancements to help bring interchangeable biosimilars to market
10 May 2019 - The U.S. FDA plays an important role in helping to address the high cost of medicines ...
Posted by Michael Wonder on 28 Apr 2019
FDA approves Samsung Bioepis' etanercept biosimilar, Eticovo
26 April 2019 - The FDA has approved Samsung Bioepis’ etanercept biosimilar, SB4, as Eticovo (etanercept-ykro). ...
Posted by Michael Wonder on 14 Apr 2019
Biopharma CEOs explain problems with biosimilars to Congress
12 April 2019 - Following their Senate Finance Committee hearing in February, all seven biopharmaceutical CEOs have now offered hundreds ...
Posted by Michael Wonder on 09 Apr 2019
Biosimilars are a distraction
8 April 2019 - Biopharmaceutical products (also known as biologics) are among the most expensive pharmaceutical products on the market, and ...
Posted by Michael Wonder on 03 Apr 2019
Sandoz resubmits biosimilar pegfilgrastim application to US FDA
2 April 2019 - Sandoz pursues US approval for biosimilar pegfilgrastim, a long-acting version of supportive oncology medicine filgrastim. ...