Eye on Pharma: Good News, Bad News for Alvotech; EpiVax Secures FDA Grant for Biosimilar Testing

As Alvotech’s biosimilars are included in a commercialization deal in the Philippines, the company hits a setback in its quest for FDA approval of its adalimumab biosimilar; the FDA gives EpiVax a $2 million grant to run immunogenicity testing for biosimilars.

Alvotech Gets Bad News and Good News

Reykjavik, Iceland–based Alvotech received a complete response letter (CRL) from the FDA for its biologics license application (BLA) for AVT02, the company’s adalimumab biosimilar referencing Humira.

The letter focused on a filed manufacturing facility inspection in March 2022. The CRL noted “deficiencies related to the Reykjavik facility and states that satisfactory resolution of the deficiencies is required before FDA may approve this BLA,” according to Alvotech’s statement.

Alvotech expressed that it will address the issues mentioned in the CRL and will continue to work with the FDA to complete the facility inspection. Mark Levick, Alvotech’s CEO, said that it still anticipates to get approval prior to its planned July 1, 2023, US launch date.

The company is looking to obtain regulatory approval and an interchangeability designation for AVT02, and the FDA is currently reviewing BLAs for both. AVT02 is available in some European markets and Canada.

Additionally, some of Alvotech’s biosimilars have an opportunity to reach a new market. As part of a commercialization agreement between Lupin Limited and DKSH, patients in the Philippines will have access to 5 biosimilars developed by Alvotech. The agreement will apply for biosimilars referencing Prolia/Xgeva (denosumab), Simponi (golimumab), Eylea (aflibercept), and 2 undisclosed products.

Multicare Pharmaceuticals, Lupin’s subsidiary in the Philippines, will be responsible for obtaining marketing approval in the country and will have the distribution and commercialization rights for the biosimilars upon approval. The biosimilars will be used to treat several bone conditions, cancer types, immune conditions, and retinal diseases.

DKSH is one of Alvotech’s commercial partners in several Asian markets, including Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh, and Pakistan.

EpiVax Secures Funding for Immunogenicity Testing

EpiVax, a Providence, Rhode Island–based company, announced that it has received a 2-year, $2 million grant from the FDA’s Officer for Center for Drug Evaluation and Research (CDER) for immunogenicity testing of biosimilars.

The analyses will validate a method for immunogenicity risk assessment of host cell proteins (HCPs) for improving the development process of biosimilar candidates and assessing the interchangeability of biosimilars. EpiVax will begin its research in September 2022 and will finish in August 2024.

“[HCPs] have strong potential to enhance immunogenicity of biological therapeutics. Rapid and accurate methods for identifying of higher risk and lower risk HCP will permit drug developers to improve the safety profile of their biologic products,” said Amy Rosenberg, MD, senior director of immunogenicity of biological therapeutics at EpiVax, in a statement.

The grant will help EpiVax assess in silico tools for screening and triaging HCPs to see whether they “induce an unwanted immune response” in patients receiving a biosimilar. Preclinical validation of in silico tools and ensuring patient access to them could improve the safety of biologic drugs and accelerate the assessment process of immunogenicity risk for biosimilars.