On March 30, in the Genentech v. Amgen trastuzumab and bevacizumab biosimilar patent litigations, Delaware District Judge Connolly ordered the appointment of a special master to handle the…
On March 30, in the Genentech v. Amgen trastuzumab and bevacizumab biosimilar patent litigations, Delaware District Judge Connolly ordered the appointment of a special master to handle the…
This week, the U.S. Court of Appeals for the Federal Circuit issued two rulings in biosimilar-related appeals from final written decisions by the Patent Trial and Appeal Board (PTAB) in…
On March 24, 2020, Alvotech HF announced that it entered into an exclusive license partnership with DKSH, a market expansion services provider, for the commercialization of AVT02, a biosimilar…
On March 13, 2020, Genentech and Amgen agreed to vacate all pre-trial deadlines and their April 20, 2020 trastuzumab biosimilar jury trial date, due to an issue with a document…
Being ten years in since the enactment of the BPCIA provides us a great opportunity to take a look back at how things have developed in the world of biosimilar…
Mylan announced on its most recent quarterly earnings call that it expects to launch its rituximab and etanercept biosimilars in Europe later this year. In discussing Mylan’s biosimilars…
The Federal Circuit has declined to reconsider its December 2019 affirmance of the district court ruling in the Amgen v. Hospira (epoetin alfa) dispute. As we have previously reported, that…
Teva and Celltrion announced yesterday that their HERZUMA (trastuzumab-pkrb) for Injection, a biosimilar to HERCEPTIN, was available in the U.S. The biosimilar has the same indications as…
As we previously reported, on February 11, 2020, Amgen sued Pfizer and its affiliate Hospira, alleging that their proposed biosimilar of Amgen’s NEULASTA (pegfilgrastim) would infringe U.S. Patent…
We have previously reported on the BPCIA Genentech v. Amgen cases relating to trastuzumab and bevacizumab. This week, Judge Connolly construed the term “following fermentation” as it relates to…