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Celltrion USA has made OMLYCLO® (omalizumab-igec) commercially available in the United States, marking the first and only FDA-approved interchangeable biosimilar to XOLAIR®. The anti-IgE antibody is now available in three doses for subcutaneous injection, following its FDA approval in March 2025 for four key indications including asthma and chronic urticaria.

Celltrion has previously partnered with other companies to market its biosimilar products in the United States.

Those exceptions include prescriptions issued during a public health emergency.

On February 23, 2025, Celltrion announced that the European Commission ("EC") approved its tocilizumab biosimilar, AVTOZMA® (CT-P47), referencing Roche's ROACTEMRA®.

On September 17, Express Scripts, Inc. ("Express Scripts"), one of the largest pharmacy benefit managers (PBMs) in the United States...

The FDA has published comprehensive guidance addressing frequently asked questions about developing cellular and gene therapy products, covering critical aspects from initial IND submissions through clinical trial design. This guidance aims to streamline the development process for safe and effective CGT products while addressing key regulatory considerations across nonclinical studies, manufacturing, and human trials.

Moderna's investigational mRNA influenza vaccine, mRNA-1010, received unanimous support from the FDA's advisory committee based on Phase 3 clinical trial data involving over 40,000 participants. The committee determined that the vaccine's benefits outweigh its risks for adults aged 50 and older, marking a significant milestone in the regulatory review process. The FDA will now consider this recommendation as part of its evaluation, with a decision expected by August 2026.

On February 17, 2026, the U.S. Food and Drug Administration (FDA) approved FILKRI (filgrastim-laha)...

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 XGEVA®, respectively.

On December 8, 2023, the FDA approved the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older—Vertex's CASGEVY and Bluebird's LYFGENIA.

On May 4, 2026, the FDA approved Lannett Company, Inc. (“Lannett”), Lanexa Biologics LLC (“Lanexa”), and Sunshine Lake Pharma’s LANGLARA (insulin glargine-aldy)...

Lupin Limited announced on December 1 that it received FDA approval for its biosimilar product, ARMLUPEG (pegfilgrastim-unne).

The U.S. FDA has approved LUMVOA (veligrotug-vvze) as the first treatment for thyroid eye disease with labeling that includes data from both active and chronic patient populations. This milestone marks Viridian Therapeutics' first FDA-approved medicine and commercial product, offering a new therapeutic option for patients suffering from this rare autoimmune disease characterized by inflammation and tissue remodeling around the eyes.

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...

On February 12, the FDA issued a final rule regarding the use of Drug Master Files ("DMF") in Biologics License Applications.

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)

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 pharmacokinetic (PK) study requirements when scientifically justified.