On April 29, 2026, the U.S. Food and Drug Administration (FDA) approved Sunshine Lake Pharma’s Langlara™ (insulin glargine-aldy) biosimilar to Sanofi’s Lantus® (insulin glargine), for the treatment of adult and pediatric...more
On May 4, 2026, the FDA approved Lannett Company, Inc. (“Lannett”), Lanexa Biologics LLC (“Lanexa”), and Sunshine Lake Pharma’s LANGLARA (insulin glargine-aldy) as an interchangeable biosimilar to Sanofi’s LANTUS (insulin...more
The U.S. Food and Drug Administration’s fiscal year 2027 budget justification includes more than 20 legislative proposals spanning drug and biologic approval pathways, supply chain oversight, advertising standards and...more
On March 9, 2026, the U.S. Food and Drug Administration (FDA) issued new draft guidance aimed at further streamlining the development of biosimilar and interchangeable biosimilar products by reducing certain clinical...more
In Fish & Richardson’s 2025 biologics and biosimilars review, we cover Food and Drug Administration (FDA) approvals, new biosimilar launches, Biologics Price Competition and Innovation Act (BPCIA) litigation and other...more
Dr. Reddy’s Laboratories (“Dr. Reddy’s”) announced on February 22 that the FDA accepted its BLA for DRL_AB, a proposed interchangeable biosimilar to Bristol-Myers Squibb’s ORENCIA® (abatacept) IV for infusion. ...more
On February 11, 2026, Regeneron and Samsung Bioepis dismissed Case Nos. 1:23-cv-00094 (N.D.W. Va.) and 1:23-cv-00106 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) due to settlement. ...more
FDA has undergone fundamental changes under the Trump administration. The agency is smaller, but is it smarter? Commissioner Makary has embraced AI and appears to be looking for new ways to abbreviate clinical development for...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
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
Many Prolia®/Xgeva® (denosumab) biosimilars approved in 2025 by FDA and EMA. FDA grants first interchangeable status for rapid acting insulin aspart, KristyTM....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 3, 2025, Celltrion announced that the FDA has approved a new dose of OMLYCLO (omalizumab-igec), the first and only biosimilar designated as interchangeable with Genentech and Novartis’s XOLAIR (omalizumab). The...more
The U.S. House of Representatives and U.S. Senate will be in session this week for the last time this year. After votes on proposals from Senate Republicans and Democrats to extend the enhanced advanced premium tax credits...more
The Food and Drug Administration ("FDA") issued two draft guidance documents that would largely eliminate clinical efficacy and switching studies and instead rely on the precision of modern analytical methods to accelerate...more
On November 13, 2025, the FDA approved Shanghai Henlius Biotech / Organon’s Poherdy® (pertuzumab-dpzb) as the first interchangeable biosimilar of Genentech’s Perjeta® (pertuzumab). Poherdy® is approved for all of the same...more
Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics impacting stakeholders....more
On November 13, 2025, the FDA approved Shanghai Henlius Biologics Co. Ltd.’s POHERDY (pertuzumab-dpzb) as an interchangeable biosimilar to Genentech’s PERJETA (pertuzumab). This is the first pertuzumab biosimilar to receive...more
The U.S. Food and Drug Administration’s (FDA) new draft guidance may reduce the cost and time to market for some applicants with biosimilar Biologic License Applications (BLAs). This draft guidance pivots from requiring...more
“By streamlining the biosimilar development process and helping advance interchangeability, we can achieve massive cost reductions for advanced treatments for cancer, autoimmune diseases, and rare disorders affecting millions...more
The Food and Drug Administration (FDA) recently announced changes to its policy on when a comparative efficacy study would be required to demonstrate biosimilarity. In essence, FDA is lopping off the top of the “biosimilarity...more
This week the FDA granted interchangeability status to Fresenius Kabi’s and Celltrion’s respective denosumab biosimilars. Interchangeable biosimilars can be substituted for the reference product at the pharmacy without...more
On September 26, 2025, Amneal / Kashiv announced the submission to the FDA of an aBLA for ADL-018, a proposed biosimilar of Genentech’s Xolair® (omalizumab)....more
A Blueprint for FDA: Recommendations to Improve Innovation and Access [1] (FDA Blueprint) is a timely white paper authored by University of Southern California scholars that identifies U.S. Food and Drug Administration (FDA)...more
The regulatory landscape for biosimilars is undergoing significant change on both sides of the Atlantic. Recent developments signal a potential shift away from the requirement for a clinical efficacy study as an approval...more