Statute
BPCIA
102 published works
Biosimilars Law Bulletin
Venue Considerations for Hatch-Waxman and BPCIA Litigation
In Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., No. 2019-2402 (Fed. Cir. Nov. 5, 2020), the Federal Circuit clarified the venue analysis of 28 U.S.C. § 1400(b), which…
Big Molecule Watch
BREAKING NEWS: Genentech and Amgen Settle HERCEPTIN and AVASTIN Biosimilar Disputes
Today, Genentech and Amgen jointly filed stipulations in the U.S. District Court for the District of Delaware dismissing their BPCIA litigations concerning Amgen’s biosimilars of Genentech’s HERCEPTIN (trastuzumab) and AVASTIN…
Big Molecule Watch
BREAKING NEWS: Federal Circuit Denies Genentech’s Appeal to Block Sales of Amgen’s MVASI (bevacizumab-awwb)
Today, in the Genentech v. Amgen BPCIA litigation concerning Amgen’s MVASI (bevacizumab-awwb) biosimilar product, the U.S. Court of Appeals for the Federal Circuit issued an opinion affirming the district court’s…
Biosimilars Law Bulletin
Biosimilar Approvals Stall During COVID-19 Pandemic, But the Pipeline Grows
FDA has not approved any biosimilars in 2020. Two Herceptin® (trastuzumab) biosimilars launch in the U.S. in Q1 2020. EMA approves third Enbrel® (etanercept), eleventh Humira® (adalimumab), seventh Rituxan® (rituximab),…
Immuno-Innovation
Ten Years Into the BPCIA—How Will Immunotherapy Biologics Fare?
March 23, 2020 marked the tenth anniversary of the enactment of the Biologics Price Competition and Innovation Act (BPCIA), which provided the approval pathway for biosimilar products. While it was…
Big Molecule Watch
Amgen Sues Pfizer and Hospira for Patent Infringement related to Hospira’s Filgrastim Biosimilar
Last week, Amgen filed a new complaint against Pfizer and Hospira under the BPCIA for infringement related to Hospira’s filgrastim biosimilar. The action is related to newly granted U.S. Patent…
Big Molecule Watch
Special Master Appointed to Decide Requests to Seal and Redact in Genentech v. Amgen BPCIA Litigations
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 parties’ requests to…
Big Molecule Watch
Top 10 Biosimilar Posts on Big Molecule Watch
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…
Big Molecule Watch
The Ten-Year Anniversary of the Enactment of the BPCIA
Today, March 23, 2020, marks ten years since President Barack Obama signed the Biologics Price Competition and Innovation Act (BPCIA) into law as part of the Affordable Care Act. The…
Big Molecule Watch
FDA Classifies Insulin as Biologic; Biosimilar Insulin Applications Accepted Beginning March 23, 2020
On February 21, the FDA published a final rule in the Federal Register that implemented a requirement of the BPCIA, transitioning insulin, and some other products such as human growth…