Tagged as: FDA

FDA Commissioner Delivers Remarks at FDA-U.S. Patent and Trademark Office Public Workshop

On January 19, 2023, the FDA Commissioner, Robert M. Califf, delivered remarks at the FDA-USPTO Public Workshop.  He noted that, since the issuance of President Biden’s 2021 Executive Order on Promoting Competition, the FDA and USPTO have been working together to leverage their combined expertise to promote competition and access…

Read More

Year in Review: Top Deals in 2022

According to PwC, “2022 has been a challenging year for M&A in the pharmaceutical and life sciences sector, with both deal value and volume at multiyear lows thanks to overall macro headwinds coupled with broad-based market dislocation.”  PwC expects “M&A to more closely resemble prior years with a total deal…

Read More

Year in Review: Top Biosimilars-Related Regulatory Developments of 2022

As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year: USPTO Outlines New Initiatives Regarding Drug Pricing In July, we reported that Katherine Vidal, the Undersecretary of Commerce for Intellectual Property and Director of the USPTO, published a letter summarizing several…

Read More

Now Available! Updated Goodwin’s Guide to Biosimilars Litigation and Regulation in the U.S., 2022-2023

As regular Big Molecule Watch readers know, the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law as part of the Affordable Care Act on March 23, 2010, creating an abbreviated licensure pathway for “biosimilar” and “interchangeable” biological products. The BPCIA also introduced a new scheme to resolve…

Read More

FDA Approves Eli Lilly’s REZVOGLAR As the Second Interchangeable Insulin Glargine

On November 16, FDA approved Eli Lilly’s REZVOGLAR (insulin glargine-aglr) as the second interchangeable biosimilar to LANTUS (insulin glargine), joining SEMGLEE (insulin glargine-yfgn), which was previously approved as interchangeable to LANTUS.  Regarding REZVOGLAR’s approval as interchangeable, FDA stated: “This approval furthers FDA’s longstanding commitment to support a competitive marketplace for…

Read More

Request for Comments on USPTO-FDA Collaboration Initiatives to Promote Generic Drug and Biosimilar Competition

On November 7, the U.S. Patent and Trademark Office (USPTO) published a request for comments on areas for USPTO-FDA collaboration and engagement. The USPTO also announced a related public listening session to be held on Thursday, January 19, 2023. As we have previously reported, President Biden issued an Executive Order…

Read More

Request for Comments on USPTO Initiatives To Promote Generic Drug and Biosimilar Competition

The U.S. Patent and Trademark Office (USPTO) recently published a request for comments addressing a variety of topics related to generic drug and biosimilar competition.  In July 2021, President Biden issued an Executive Order on “Promoting Competition in the American Economy,” which directed the Secretary of Health & Human Services…

Read More

Biocon and Alvotech Release Statements on FDA Inspections

On August 31, 2022, Biocon Biologics released a statement regarding three recent on-site FDA inspections of seven manufacturing facilities spanning two sites in Bengaluru, India and one site in Johor, Malaysia.  The inspections took place between August 11 and August 30, 2022.  The inspections were triggered by three preapproval inspections…

Read More

Biosimilar Regulatory Approval Updates

Teva announced today that the European Commission has granted marketing authorization for RANIVISIO, a biosimilar ranibizumab, for the treatment of age-related macular degeneration (AMD).  Teva entered into a strategic partnership with Bioeq AG for the exclusive commercialization of ranibizumab.  According to the press release, RANIVISIO (ranibizumab) will be the first…

Read More