Biocon, a prominent Indian biopharma company, entered into a partnership with Mylan in 2009 for joint research and development of biosimilars. That partnership now appears to be yielding results. The companies expect to submit regulatory filings in both the U.S. and EU 2016: trastuzumab, pegfilgrastim, adalimumab, and insulin glargine. As Big…
IPR2015-01624 (U.S. Patent No. 6,331,415) (Sanofi-Aventis and Regeneron) (Cabilly patent) – Institution of IPR The PTAB has instituted IPR on U.S. Patent No. 6,331,415.
Today, Sandoz announced that the EMA has accepted its Marketing Authorization Application for its biosimlar to Amgen’s Neulasta, used to prevent infection in patients with compromised immune systems due to chemotherapy. Sandoz’s application is supported by three pivotal clinical trials.
Yesterday, the FDA’s Advisory Committee overwhelmingly supported approval of Celltrion’s infliximab product, which is a biosimilar for Janssen’s Remicade product. At the District Court status conference in Janssen v. Celltrion, which followed the Advisory Committee vote, Celltrion’s counsel said that Celltrion is expecting FDA approval in about four to eight…
Following FDA support announced last Friday for Celltrion’s proposed Remicade® biosimilar (“CT-P13”), the FDA is holding an Advisory Committee meeting today to discuss Celltrion’s application. On Friday, the FDA said that based on its review of the data, Celltrion’s CT-P13 has been demonstrated to be highly similar to Remicade, notwithstanding…
Amgen has filed its reply brief in Amgen v. Apotex, which is currently on appeal before the Federal Circuit. The brief is available here. As we covered previously, Apotex filed an appeal in the Federal Circuit after the district court granted Amgen a preliminary injunction to prevent Apotex from marketing its…
The House Energy & Commerce Committee’s Subcommittee on Health met this morning to discuss implementation of the Biologics Price Competition and Innovation Act. Sean Cavanaugh, Deputy Administrator and Director of the Center for Medicare, and Janet Woodcock, Director of the Center for Drug Evaluation and Research, testified. The subcommittee’s questioning…
Japan’s Ministry of Health, Labor, and Welfare has proposed a plan to lower prices of generic and biosimilar drugs across the pharmaceutical industry. Under the proposed plan, generic drugs will be priced at 40% of brand-name drug prices, while “[b]iotechnology-based generics, such as genetically modified drugs, will be initially priced…
Coherus announced yesterday “a key achievement in support of [its] planned Biologics License Application (BLA) filing” for a proposed biosimilar of Amgen’s Neulasta® (pegfilgrastim): its proposed biosimilar, CHS-1701, has “met both primary endpoints in a double-blind, randomized, two-period, parallel-arm clinical study in 303 healthy subjects.” If accepted for FDA review,…
For the past couple of years, the World Health Organization (“WHO”) has been hard at work devising a system for standardizing the nonproprietary names of biological active substances. As we reported in an earlier post, the WHO has proposed introducing a Biological Qualifier (“BQ”), a code consisting of four random…