Tagged as: BPCIA

New BPCIA Complaint: Genentech Files Suit Against Tanvex Regarding its Proposed Herceptin Biosimilar

Genentech filed a complaint yesterday against Tanvex in the U.S. District Court for the Southern District of California, alleging infringement of three patents under the BPCIA based on Tanvex’s submission of an aBLA for TX05, a proposed biosimilar of HERCEPTIN (trastuzumab).  Genentech asserts that Tanvex’s process for manufacturing TX05 infringes…

Read More

FDA Approves First New Biosimilar of 2020

On June 10, 2020, the U.S. Food and Drug Administration (FDA) approved Pfizer’s NYVEPRIA (pegfilgrastim-apgf), a biosimilar of Amgen’s NEULASTA. NYVEPRIA is indicated to “decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of…

Read More

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 seal various court filings.  Judge Connolly stated that “[r]ecent sealed and redacted filings in these related cases make clear that…

Read More

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 BPCIA—whose legislation certain members of the Big Molecule Watch team were involved in drafting—created an abbreviated regulatory pathway for seeking…

Read More