Tagged as: FDA

Purple Book Updates

FDA’s Purple Book provides a searchable database of licensed biological products and includes the patent information provided to biosimilar applicants during the BPCIA patent dance.  Pursuant to a law enacted in late 2020, a reference product sponsor must provide patent information to FDA for listing in the Purple Book once…

Read More

FDA Guidance on Continuous Manufacturing of Drug Substances and Drug Products

In March 2023, the FDA issued a final guidance, titled “Q13 Continuous Manufacturing of Drug Substances and Drug Products” that describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM).” CM refers to “the continuous feeding of input materials into, the transformation of…

Read More

USPTO Extends Deadline for Comments on USPTO-FDA Collaboration Initiatives

On February 24, the USPTO extended the written comment period for Joint USPTO–FDA Collaboration Initiatives until March 10, 2023.  As we previously reported, the USPTO requested public input on areas for USPTO-FDA collaboration and engagement in response to President Biden’s Executive Order to “help ensure that the patent system, while incentivizing…

Read More

Sandoz Denosumab BLA Accepted by FDA

The US FDA has accepted a Biologics License Application (BLA) from Sandoz for a proposed denosumab biosimilar. In its press-release, Sandoz stated that the “application includes all indications covered by the reference medicines Prolia® (denosumab)* and Xgeva® (denosumab)* for treating a variety of conditions, including osteoporosis in postmenopausal women and…

Read More

FDA Issues CRL for Biocon/Viatris Bevacizumab Biosimilar

On Feb 12, 2023, Biocon Biologics announced that the FDA issued a Complete Response Letter (CRL) for its Biologics License Application (BLA) for its biosimilar referencing AVASTIN (bevacizumab), previously submitted by Viatris.  Biocon Biologics completed the multi-billion dollar acquisition of Viatris’s global biosimilar business in December 2022.  The CRL relates…

Read More

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