Two and a half years after the initial proposal, agreement has been reached by the EU institutions on the so-called EU Pharma Package. The Package represents a comprehensive overhaul of the European Union’s pharmaceutical...more
Just in December, six companies have announced the launch of their denosumab biosimilars in Europe: Sandoz, Samsung Bioepis, Fresenius Kabi, Zentiva, Biocon Biologics, and Accord. ...more
After the Council of the European Union (Council) adopted its negotiation position on the so-called Pharma Package in June 2025, the Council and the European Parliament have now reached an agreement in the trilogue...more
Clinical trial research, like medicine more generally in the European Union (EU), is regulated by a network of national competent authorities from each of the Member States of the European Economic Area (EEA) working with the...more
Our FDA: Drug & Device Team examines the FDA’s new draft guidance that allows biosimilar developers to rely more on analytical and pharmacokinetic data, reducing the need for costly and time-consuming comparative efficacy...more
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 (recombinant zoster vaccine)...more
As the global cannabis landscape continues to evolve, the European nation of Malta has emerged as a trailblazer, despite its population of just over 500,000. In 2018, it established a robust framework for medical cannabis,...more
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 Novartis AG’s...more
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. ...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
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 named EYLUXVI. ...more
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 the LP.8.1 variant of...more
In its June 2025 meeting, the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) adopted positive opinions for six biosimilar medicines. ...more
On June 25, 2025, Kashiv BioSciences announced positive topline results from its confirmatory Phase 3 trial of ADL-018, a proposed biosimilar to XOLAIR® (omalizumab), in patients with chronic spontaneous urticaria. ...more
On May 27, 2025, Fresenius Kabi (“Fresenius”) announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) had issued positive opinions for Fresenius’s two denosumab biosimilar candidates....more
Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more
The European Medicines Agency (EMA) published a workplan on its ambition to leverage high volumes of data and artificial intelligence (AI). On 7 May 2025, the European Medicines Agency (EMA) published a joint workplan with...more
Last week, Biocon Biologics Ltd (“BBL”) announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) had issued positive opinions for Biocon’s two denosumab biosimilar candidates....more
This week, CuraTeQ Biologics (a wholly owned step-down subsidiary of Aurobindo Pharma Limited) announced that its trastuzumab biosimilar, DAZUBLYS, has received a positive opinion from the European Medicines Agency Committee...more
On April 1, 2025, the European Medicines Agency opened the consultation period for its draft reflection paper on a tailored clinical approach in biosimilar development....more
On April 2, 2025, Accord received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for two denosumab biosimilars: OSVYRTI and JUBEREQ. OSVYRTI is indicated for the...more
On February 10, 2025, Bio-Thera Solutions, Ltd. announced that they entered into an exclusive licensing agreement with Intas Pharmaceuticals Ltd. to commercialize BAT2506 (golimumab), Bio-Thera’s proposed biosimilar of...more
CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars: On January 30, 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending...more
Pharma: Launch of Shortages Monitoring Platform, several Changes re Clinical Trial Management in EU Countries; Devices: Resolution on the need to revise the MDR and IVDR published; Compliance: CSRD still not implemented in...more
Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a more...more