For just the tenth time since the implementation of the BPCIA, the FDA has approved a biosimilar product. Today, the FDA announced that it has approved Pfizer-subsidiary Hospira’s…
For just the tenth time since the implementation of the BPCIA, the FDA has approved a biosimilar product. Today, the FDA announced that it has approved Pfizer-subsidiary Hospira’s…
Over the past few weeks, numerous biologics and biosimilar companies released their quarterly earnings for Q1 2018 and held related earnings calls. Below are some highlights: On April 17,…
Over the past week, biopharmaceutical developers from around the world provided updates on the development and availability of a number of biosimilar products and candidates. Below are…
We previously reported that in the ongoing Genentech v. Amgen litigation regarding Amgen’s proposed bevacizumab biosimilar, Mvasi™, Amgen moved to dismiss Genentech’s declaratory judgement…
AbbVie recently announced positive results for upadacitinib, a small molecule Janus Kinase (JAK) inhibitor, in a phase 3 clinical trial of patients with rheumatoid arthritis (RA). According to…
Pegfilgrastim litigation We had previously covered Judge Stark’s grant of Coherus’s motion to dismiss Amgen’s complaint alleging infringement of the ‘707 patent in Amgen v….
Today, AbbVie and Samsung Bioepis announced that they have reached a global resolution of all intellectual property-related litigation relating to Samsung Bioepis’ biosimilar of Humira®…
Biocon announced yesterday that it has received marketing authorization approval from the European Commission for Semglee™ (insulin glargine). The decision came after receiving a…
Over the past several weeks, there have been numerous developments in U.S. patent litigation activity relating to biosimilars of Neupogen® (filgrastim) and Neulasta® (pegfilgrastim). Below is…
Last week the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) recommended two biosimilar medicines for approval. First,…