On November 17, 2025, Sandoz announced the launch of TYRUKO® (natalizumab-sztn) in the United States as the first and only biosimilar for the treatment of relapsing forms of multiple sclerosis.

On November 12, 2025, Sandoz announced a licensing agreement with EirGenix to commercialize EG1206A (pertuzumab), a proposed biosimilar of Genentech’s PERJETA® (pertuzumab).

On November 14, 2025, Amgen, Inc. (“Amgen”) launched another BPCIA denosumab litigation when it filed a complaint in the U.S. District Court for the District of New Jersey against Alkem Laboratories L...

On November 20, 2025, the FDA approved Accord BioPharma’s denosumab biosimilars OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu), which reference Amgen’s PROLIA® and XGEVA®, respectively.  This...

On November 11, 2025, Sanofi and Regeneron announced that the FDA accepted for priority review its supplemental biologics license application (“sBLA”) for Dupixent (dupilumab) in the treatment of adul...

On November 12, 2025, Regeneron filed a Motion to Strike Certain Affirmative Defenses and Dismiss Certain Counterclaims against Amgen in the aflibercept patent litigation in the U.S. District Court fo...

On November 7, Vera Therapeutics announced that it submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) through the Accelerated Approval Program for atacicept...

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 pertuzum...

In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce clinical testing for therapeutic protein products.

On November 6, 2025, Amgen, Inc. (Amgen) launched a new round of BPCIA denosumab litigations when it filed two cases in the U.S. District Court for the District of New Jersey, one against Dr. Reddy's ...

On November 6, 2025, Hikma Pharmaceuticals PLC, and its subsidiary Hikma Pharmaceuticals USA Inc., announced the launch of STARJEMZA (ustekinumab-hmny).

On November 3, 2025, Samsung Biologics announced the completion of the spin-off of its investment and subsidiary management business unit, and the establishment of Samsung Epis Holdings, an investment...

On October 21, 2025, GSK announced that the European Medicine Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion for the shingle vaccine SHINGRIX (reco...

In the last few weeks, Health Canada issued several decisions concerning biologics. On October 17, Health Canada approved, via a Notice of Compliance, Biocon Biologics Ltd.’s YESINTEK (ustekinumab inj...

Last week, Takeda announced that it has entered into a worldwide license and collaboration agreement (outside of Greater China) with Innovent Biologics for the development, manufacture, and commercial...

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 t...

On October 20, 2025, Teva Pharmaceuticals International GmbH (“Teva”) announced a licensing agreement with Prestige BioPharma Ltd. (“Prestige BioPharma”) to commercialize TUZNUE® (trastuzumab), a bios...

On October 20, 2025, the FDA approved Genentech’s GAZYVA® (obinutuzumab) as a treatment for adults with lupus nephritis (LN).  Gazyva is a type II humanized anti-CD20 monoclonal antibody that works by...

On October 17, Governor Newsom announced that California will be launching the “first and only” state contracted affordable insulin. Through an agreement with nonprofit generic drug manufacturer Civic...

As we have previously reported, on June 21, 2023, the FDA accepted Xbrane’s sBLA for LUCAMZI, a proposed ranibizumab biosimilar to Genentech’s LUCENTIS (ranibizumab).

On October 17, 2025, Amgen and AstraZeneca announced that the FDA has approved an additional indication for TEZSPIRE (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled ...

On October 9, 2025, the FDA approved Celltrion’s aflibercept biosimilar, EYDENZELT® (aflibercept-boav) referencing Regeneron’s EYLEA® (aflibercept).

On October 2, 2025, Celltrion, Inc. (“Celltrion”) announced the commercial launch of AVTOZMA® (tocilizumab-anoh), a biosimilar to ACTEMRA® in the United States.

On September 26, Amneal Pharmaceuticals, Inc. announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ADL-018, a proposed biosimilar to Nov...

On September 30, 2025, the U.S. District Court for the Northern District of California ordered Biogen MA, Inc. (Biogen) to pay Genentech, Inc. (Genentech) $88,348,123 in unpaid royalties plus interest...

On September 18 and 19, 2025, the Patent Trial and Appeals Board (PTAB) issued final written decisions for four inter partes review (IPR) challenges brought by Merck Sharp & Dohme LLC (Merck) against ...

On September 5, 2025, the U.S. District Court for the District of New Jersey entered a Consent Order and Judgment resolving the denosumab BPCIA litigation between Amgen, Inc. (Amgen) and Samsung Bioep...

On September 30, the U.S. District Court for the Eastern District of Virginia granted in part and denied in part the Motion to Dismiss filed by Amgen, Inc. and Immunex Corporation (Amgen) in a class a...

On September 29, 2025, Gedeon Richter Plc. (“Richter”) and Hikma Pharmaceuticals Plc. along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc.

The aflibercept multi-district litigation consists of multiple actions consolidated in the Northern District of West Virginia, with Regeneron Pharmaceuticals, Inc. (“Regeneron”) filing suit under the ...

In the past few weeks, several biosimilar products have been granted marketing authorization in Europe and Japan, and additional products have been recommended for approval in Europe.

On September 26, 2025, Factor Bioscience Inc. (“Factor”) filed a complaint against Cellectis Inc., Cellectis SA, AstraZeneca PLC, AstraZeneca Ireland Limited, and AstraZeneca Holdings B.V., alleging i...

On September 16, 2025, the FDA approved Biocon Biologics Ltd.’s BOSAYA™ (denosumab-kyqq) and AUKELSO™ (denosumab-kyqq) as biosimilars to Amgen’s PROLIA® and XGEVA®, respectively.

As we previously reported, on June 17, 2025, Regeneron filed a complaint against Amgen under the BPCIA, alleging that Amgen’s aflibercept biosimilar, PAVBLU, infringes U.S. Patent No. 12,331,099 (“the...

On September 17, 2025, Alvotech USA Inc. and Alvotech hf. (Alvotech) filed a Petition for Post Grant Review of U.S. Patent No. 12,168,036 (the '036 patent), assigned to Regeneron Pharmaceuticals, Inc....

This month, FDA issued its new final guidance to replace a draft guidance that issued on May 22, 2019 titled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Othe...

The Bayh-Dole Act provides that the federal government retains certain rights in inventions it funds.  Many have sought to use those rights as a way to lower the cost of prescription drugs for consumers and for the federal government.

On September 9, 2025, the District Court for the Northern District of West Virginia entered a Stipulation and Order dismissing all claims and counterclaims in view of a settlement agreement between Sa...

On September 2, 2025, Shanghai Henlius Biotech, Inc. and Organon announced that the FDA has approved BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp) as denosumab biosimilars to Prolia® and X...

On August 21, 2025, Alvotech and Advanz Pharma Holdco Limited (Advanz) announced that MYNZEPLI®, a biosimilar of Regeneron's EYLEA® (aflibercept), was approved by the European Commission.

On August 7, 2025, Celltrion announced that it obtained FDA approval expanding the indication of the intravenous (IV) formulation of AVTOZMA (tocilizumab-anoh) to include treatment of cytokine release...

On August 12, 2025, Lupin Limited (“Lupin”) announced that it has partnered with Sandoz Group AG (“Sandoz”) to market and commercialize Lupin’s biosimilar ranibizumab across multiple regions.

On August 18, 2025, Accord BioPharma, Inc. (“Accord BioPharma”) announced the commercial launch of IMULDOSA® (ustekinumab-srlf), a biosimilar to STELARA® (ustekinumab) in the United States.  IMULDOSA®...

We previously reported that South Korean biopharmaceutical company Alteogen submitted its Marketing Authorization Application to the European Medicines Agency (“EMA”) for ALT-L9, what has since been n...

On July 30, 2025, Moderna announced that the European Commission (EC) granted marketing authorization for the updated formulation of Moderna's COVID-19 vaccine Spikevax®.  The updated vaccine targets ...

On July 24, 2025, Acting Director of the USPTO, Coke Morgan Stewart, denied institution of inter partes review in IPR2025-00601 and IPR2025-00602, but referred the petition in IPR2025-00603 to the Boa...

On August 14, 2025, Genentech, Inc. and Hoffman-La Roche Inc. (together, “Genentech”) filed a BPCIA complaint in the U.S. District Court of New Jersey against Shanghai Henlius Biotech, Inc. and Shangh...

On August 1, 2025, a UK Court of Appeal upheld the validity of Moderna’s European Patent No. 3,590,949 (“EP’949”) in a dispute with Pfizer and BioNTech.

On July 30, 2025, the U.S. District Court for the District of Delaware entered a Final Judgment in the dispute between Alnylam Pharmaceuticals, Inc. (“Alnylam”) and Pfizer, Inc.

On June 26, 2025, Formycon AG (“Formycon”) announced a distribution agreement with Teva Group subsidiary Ratiopharm GmbH (“Ratiopharm”) for the semi-exclusive commercialization of its Stelara biosimil...