Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Drug Pricing Initiatives During the Trump Presidency
A changing competitive landscape: the role of the ITC in the biosimilars space
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
On January 12, 2026, Sanofi announced that the European Commission approved its Teizeild (teplizumab) for delaying progression to stage 3 type 1 diabetes (“T1D”) in adults and children eight years and older who have stage 2...more
On January 30, 2026, the U.S. District Court for the District of New Jersey entered a Joint Stipulation of Dismissal resolving the pertuzumab BPCIA litigation between Genentech, Inc. and Hoffmann-La Roche Inc. (together,...more
On January 30, 2026, the Court ordered Genentech / Hoffmann-La Roche and Shanghai Henlius Biotech / Organon’s stipulated dismissal of Case No. 2:25-cv-14648 (D.N.J.) due to a settlement agreement between the parties. ...more
Welcome to Alston & Bird’s introduction to biological products regulation. In this five-part intro-level series, we provide answers to a number of questions drug developers may have about the regulation and regulatory pathway...more
On January 13, 2026, Shanghai Henlius Biotech announced the FDA acceptance of an aBLA for HLX04, its proposed biosimilar of Genentech’s Avastin® (bevacizumab). ...more
In the evolving biosimilar landscape, patent challenges remain a critical strategy to clear the path for market entry. Recent reforms at the Patent Trial and Appeal Board (PTAB) under Director John Squires have significantly...more
On January 21, 2026, as part of an earnings call, Dr. Reddy’s announced the filing of an aBLA for an intravenous (IV) formulation of DRL_AB (abatacept), a proposed biosimilar of Bristol-Myers Squibb’s Orencia® (abatacept) in...more
In the first year of the second Trump administration, we have seen the Food and Drug Administration (FDA) take an unprecedented role in drug pricing policy....more
On January 19, 2026, Hikma announced the launch of Enoby™ / Xtrenbo™ (denosumab-qbde), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab), following their FDA-approval in September 2025. ...more
Many Prolia®/Xgeva® (denosumab) biosimilars approved in 2025 by FDA and EMA. FDA grants first interchangeable status for rapid acting insulin aspart, KristyTM....more
Speaking at the 2026 J.P. Morgan Healthcare Conference, Hogan Lovells global regulatory partners Elizabeth Jungman and Brian Carey moderated a panel discussion with U.S. Food and Drug Administration (FDA) Deputy Chief of...more
Key Takeaways: Supreme Court to decide if “generic version” marketing can support induced infringement claims. On Jan. 16, 2026, the Court granted Hikma’s petition for cert. in a closely watched case that could redefine...more
This past year contained a number of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top three legal developments that we covered on the Big Molecule Watch last...more
In 2025, the Rx IP Update team at Smart & Biggar reported on a number of developments in Canadian life sciences IP and regulatory law. Highlights from 2025 are below...more
As we head into what is anticipated to be a strong year for biopharma dealmaking, we look back at some of the biggest deals in 2025 that focus on biologics and biosimilars....more
On December 18, 2025, the FDA approved Formycon and Zydus’s Nufymco™ (ranibizumab-leyk) as the third interchangeable biosimilar of Genentech’s Lucentis® (ranibizumab). Lucentis® biosimilars have been on the market since July...more
On December 19, 2025, the FDA approved Amneal / mAbxience’s Boncresa™ / Oziltus™ (denosumab-mobz) as the nineth biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). ...more
On December 3, 2025, Fresenius Kabi and SamChunDang Pharm announced the FDA acceptance of their aBLA for SCD-411 (aflibercept), a proposed biosimilar of Regeneron’s EYLEA® (aflibercept). Under their licensing agreement...more
On November 28, 2025, the Federal Court of Appeal (FCA) upheld an injunction against the use of the trademark BYOOVIZ for an ophthalmic biosimilar, confirming the application judge’s finding that the mark is likely to be...more
On November 27, 2025, Celltrion announced that Health Canada approved EYDENZELT® (aflibercept-boav), a biosimilar referencing Regeneron’s EYLEA® (aflibercept), in both vial and pre-filled syringe form, to treat all...more
A recent judgment of the U.K. High Court (Patents Court) has clarified the scope of the notification requirements for the supplementary protection certificate (SPC) manufacturing waiver in the U.K. ...more
On December 22, 2025, the FDA approved mAbxience and Amneal’s Biologics Licensing Applications (BLAs) for BONCRESA™ (denosumab-mobz) and OZILTUS™ (denosumab-mobz), biosimilars referencing Amgen’s PROLIA® (denosumab) and...more