Amgen now has company as the second biosimilar competitor to Herceptin® has launched. On December 2, 2019, Mylan and Biocon announced the availability of Ogivri in the United States. A price for the new biosimilar was not announced, but it is assumed that they will need to meet or beat Amgen’s initial offering, which was … Continue reading Partners Mylan and Biocon Announce Launch of Trastuzumab Biosimilar Ogivri®
Tag: Mylan/Biocon
New Legislative Proposals Offer Hope to Insulin Follow-on Manufacturers
This may be good news for partners Mylan and Biocon: Two bills are circulating on Capitol Hill that can alter the transition of insulins to biologic agents in March 2020. However, the timing for passage of these bills is questionable. The Senate’s Affordable Insulins Approval Now Act (S.2103), a bipartisan bill that was introduced by … Continue reading New Legislative Proposals Offer Hope to Insulin Follow-on Manufacturers
Biocon and Mylan: The Race to Approve Insulin Glargine Follow-on
Biocon received a second complete response letter relating to manufacturing plant problems in Malaysia. This may seem like a straight forward issue that could hamper its efforts to produce an insulin glargine follow-on agent, but it can become a major problem barring a very quick resolution. In the filing Biocon made to the India Stock … Continue reading Biocon and Mylan: The Race to Approve Insulin Glargine Follow-on
Mylan’s Fulphila Pegfilgrastim Biosimilar Launches at Big Discount
The first pegfilgrastim biosimilar (Fulphila™) in the US has begun marketing, and Mylan/Biocon are offering a 33% discount to the wholesale acquisition cost (WAC) of the originator product Neulasta®. The Center for Biosimilars reported a communication from Mylan confirming the action. This is a watershed moment for the pegfilgrastim category and could signal the beginning of … Continue reading Mylan’s Fulphila Pegfilgrastim Biosimilar Launches at Big Discount
FDA Approval Eludes Amgen for Biosimilar Trastuzumab
Amgen will have to wait a bit longer to market its biosimilar version of trastuzumab . On Friday, June 1, the Food and Drug Administration (FDA) rejected Amgen’s 351(k) application for its Herceptin® biosimilar. In a brief press release, Amgen announced receiving the complete response letter for ABP 980. In the announcement, it also said that the … Continue reading FDA Approval Eludes Amgen for Biosimilar Trastuzumab
What Is the Biosimilar Pegfilgrastim Market Opportunity?
We’ve covered the contest to bring a biosimilar pegfilgrastim to market, with considerable depth. The progress and setbacks of Mylan/Biocon, Coherus Biosciences, Sandoz, and Apotex have been tracked. Other drug makers are also working on plans towards 351(k) applications for approval. Eventually—likely sooner than later—one or two will hit the market. Biosimilar Pegfilgrastim, Neulasta®, and … Continue reading What Is the Biosimilar Pegfilgrastim Market Opportunity?