Eye on Pharma: FDA, EMA Accept Biosimilar Applications; Biosimilar Trials Begin

The FDA and the European Medicines Agency (EMA) accepted applications for a trastuzumab biosimilar and an ustekinumab biosimilar...

The FDA and the European Medicines Agency (EMA) accepted applications for a trastuzumab biosimilar and an ustekinumab biosimilar, respectively, and Altos Biologics completed patient enrollment for a phase 3 trial assessing an aflibercept biosimilar.

Biosimilar Regulatory Progress

The FDA accepted a biologics license application for a biosimilar referencing Herceptin (trastuzumab) developed by Shanghai Henlius Biotech and Accord BioPharma. The biosimilar (HLX02) has been approved in more than 30 countries, including those within the European Union, where it’s marketed under the name Zercepac.

If approved, HLX02 will become the sixth trastuzumab biosimilar to receive regulatory approval and it will be used to treat human epidermal growth factor receptor 2 (HER2)-positive breast cancer. It will also be used in patients with HER2-positive metastatic gastric cancer. HLX02 is the first China-developed monoclonal antibody approved in China and the European Union.

As part of its licensing agreement with Shanghai Henlius Biotech, Accord BioPharma will be responsible for obtaining regulatory approval as well as commercializing and developing HLX02 in the United States and Canada.

“Henlius independently developed HLX02 in accordance with [China’s] National Medical Products Administration, the EMA, the FDA and other international biosimilar guidelines…. As breast cancer has become the most prevalent cancer in the world, trastuzumab has been the cornerstone of treating HER2-positive cases. In collaboration with Accord, we look forward to bringing HLX02 to more patients around the world,” said Jason Zhu, president of Shanghai Henlius Biotech, in a statement.

Additionally, the EMA accepted a marketing authorization application for a biosimilar referencing Stelara (ustekinumab) that was created by STADA Arzneimittel and Alvotech. The companies said that they anticipate the EMA’s final decision for the biosimilar (AVT04) to come as soon as the second half of 2023.

“We are pleased to be able to move closer to making AVT04 available to patients in Europe…. Our goal is to meet an increasing need for broader access to affordable biologic medicines and Alvotech’s end-to-end biosimilars platform is designed to support the development and manufacture of multiple products simultaneously,” commented Joseph McClellan, chief scientific officer of Alvotech.

If approved, STADA Arzneimittel would commercialize the product and it would be used to treat several inflammatory conditions, including rheumatoid arthritis and plaques psoriasis.

The news comes after Alvotech announced that its confirmatory safety and efficacy analysis of AVT04 compared with Stelara met its primary end points, demonstrating therapeutic equivalence between the biosimilar and reference product in patients with severe chronic plaque psoriasis.

Clinical Trials Begin

Altos Biologics, a subsidiary of Alteogen, announced that it has completed patient enrollment for a global phase 3 clinical trial. The study would assess the safety and efficacy of the company’s aflibercept biosimilar compared with the reference product (Eylea) in patients with neovascular age-related macular degeneration (wet AMD).

The ALT-L9 trial is a randomized, double-masked, parallel group multicenter study containing 431 patients with wet AMD. The study builds upon a phase 1 study that successfully demonstrated similar pharmacokinetic and safety profiles of the biosimilar compared with the originator product.

Additionally, Minapharm Pharmaceuticals began a phase 1 trial in Germany for its adalimumab biosimilar candidate, Adessia. The biosimilar references Humira (adalimumab) and was developed for the Middle East region and all of Africa as a treatment for many chronic conditions, including rheumatoid arthritis and inflammatory bowel disease.


biosimilartrastuzumabHerceptinHLX02Zercepacbreast cancermonoclonal antibody