Goodwin and the Big Molecule Watch team are looking forward to participating in the 36th Annual J.P. Morgan Healthcare Conference, bringing together industry leaders from across the country. If you are planning to attend the conference in San Francisco, we hope you will join the team next Wednesday, January 10,…
On December 29, Mylan and Biocon announced that their trastuzumab biosimilar, Zedora, was approved by Brazil’s National Sanitary Surveillance Agency. Zedora, a biosimilar of Genentech and Roche’s Herceptin, is indicated for the treatment of overexpressing HER2-positive metastatic breast cancer, HER2-positive early stage breast cancer, and HER2-positive advanced gastric cancer. Zedora…
Here are our picks for the top-5 biggest deals in the world of biosimilars in 2017: 5. Companies developing biosimilar products continue to establish partnerships to market and distribute the products on a regional basis. For example, Celltrion and Nippon Kayaku entered into an agreement under which Nippon Kayaku will sell Truxima®, Celltrion’s…
Here are our picks for the top-five most significant legal developments regarding biosimilars in 2017: 5. In January 2017, the FDA released a draft guidance on biosimilar interchangeability, entitled “Considerations in Demonstrating Interchangeability With a Reference Product.” The guidance provides an overview of scientific considerations for demonstrating the interchangeability of a biosimilar…
Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017: 1. Compared to three approvals in 2016, the FDA approved five biosimilar products in 2017: Renflexis® (infliximab-abda) Cyltezo® (adalimumab-adbm) Mvasi® (bevacizumab-awwb) Ogivri® (trastuzumab-dkst) Ixifi® (infliximab-qbtx) In a press release regarding the approval for…
Here are our picks for the top-five most significant foreign market developments in the world of biosimilars in 2017: The European, Latin American, and Asian markets are thriving with biosimilar applications and approvals. For example, a rituximab biosimilar was approved in Latin America. The EMA issued marketing approvals for at…
In response to an FDA request for comments regarding existing requirements for biologics and biosimilars, the American College of Rheumatology (ACR) submitted a letter identifying six “minimum components of review and oversight.” The FDA’s request for comments was made pursuant to President Trump’s executive order regarding the reduction of regulation…
We previously reported that on September 12, 2017, the FDA accepted for review Sandoz’s aBLA for a proposed biosimilar of Rituxan® (rituximab), which is indicated for the treatment of certain blood cancers and immunological diseases. Yesterday, Genentech filed a complaint in the District of New Jersey based on Sandoz’s proposed rituximab biosimilar, Rixathon/GP2013. Genentech…
As we previously reported, last month a Federal Circuit panel affirmed the district court’s judgment that Apotex’s pegfilgrastim and filgrastim biosimilar candidates do not infringe Amgen’s protein refolding method patent. Amgen’s time for filing a petition for panel rehearing or rehearing en banc of last month’s panel decision expired on…
Yesterday, Samsung Bioepis announced that the FDA has accepted for review the company’s BLA under the 351(k) pathway for SB3, a biosimilar candidate referencing Genentech’s Herceptin® (trastuzumab). The press release states that this is Samsung Bioepis’ first submission for FDA-approval of an oncology biosimilar candidate. According to the press release,…