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,…
Yesterday, in Ericsson Inc. v. Regents of the University of Minnesota, an expanded 7-judge PTAB panel ruled that a patent owner waives a claim to sovereign immunity in an IPR “by filing an action in federal court alleging infringement of the patent being challenged in [the IPR] proceeding.” The PTAB…
On December 16, Celltrion announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Herzuma, its trastuzumab biosimilar. The CHMP has recommended that Herzuma be approved for the treatment of “early breast cancer, metastatic breast…
As we previously reported, in Amgen v. Sandoz, which relates to both Sandoz’s filgrastim biosimilar (Zarxio) and its pegfilgrastim biosimilar, Sandoz had filed motions for summary judgment regarding non-infringement of Amgen’s ‘878 patent — the only remaining patent at issue in the case — and damages. Amgen opposed both motions, and…
The FDA published two draft guidances for comment this week: “Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease” and “Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research.” The guidance on targeted therapies is intended to provide guidance on…
Fresenius Kabi today announced it has submitted an application seeking marketing authorization for its biosimilar version of Humira® (adalimumab) in the EU. This is Fresenius Kabi’s first biosimilar regulatory filing. Four adalimumab biosi.0milar products have been approved in the EU: Amgen’s AmgevitaTM and Solymbic, Samsung Bioepis’s Imraldi®, and Boehringer Ingelheim’s…