ANVISA (Agência Nacional de Vigilância Sanitária), the National Health Surveillance Agency of Brazil, published in November 2022 three new guidance documents on the regularization of biological, biosimilar and radiopharmaceutical products.

Results of clinical patient trials of Alvotech’s high concentration formulation biosimilar of adalimumab, AVT02, demonstrate comparable efficacy, safety and immunogenicity to the reference product Humira, according to a study published in Biodrugs [1].

A 2022 report entitled ‘The U.S. Journey and Path Ahead’ provides perspective on where the US biosimilars industry stands today and what is expected in the future. The publication brought together the latest industry data on biosimilar utilization and payer coverage with survey data from healthcare providers, and thoughts from physicians and experts on biosimilars.

The etanercept biosimilar Rymti, produced by Lupin, received approval from Canada’s drug regulator, Health Canada (HC), on 13 September 2022, for all indications of the reference product Enbrel. This is the third etanercept biosimilar to receive approval in Canada [1].

As of October 2022, US Food and Drug Administration (FDA) has updated four guidances to address new commitments made in the latest Generic Drug User Fee Amendments (GDUFA III) programme. To enhance the ability to have productive discussion about prospective products, the guidances now include provision to permit and remote meetings between FDA and prospective and current abbreviated new drug application (ANDA) applicants.

Following the establishment of biosimilarity, there are no regulations that require manufacturers to perform quality or clinical studies to compare biosimilar versus originator products post-approval. In an investigation published in GaBI Journal [1], Dr Pablo Matar examined the concept of biosimilar manufacturing ‘drift’ and product divergence [2].

In November 2022, Alvotech announced that the Therapeutic Goods Administration (TGA) of Australia has granted marketing authorization for its a high-concentration low-volume adalimumab, AVT02, a biosimilar referencing Humira and marketed by their partner, Cipla Australia. In addition, Stada Arzneimittel and Xbrane Biopharma announced that the European Commission granted marketing authorization for their Ximluci (ranibizumab), a biosimilar candidate referencing Lucentis. 

Biocon Biologics announced on 17 October 2022 that it has entered into a strategic out-licensing agreement with Japanese pharmaceuticals company Yoshindo for commercializing two of its pipeline biosimilar assets in Japan. Following this, on 2 November 2022, Syna Therapeutics signed an exclusive license agreement with Intas to commercialize a haematology biosimilar.

The European Commission had opened a public consultation on ‘Intellectual property (IP) – revised framework for compulsory licensing of patents’. This was opened from 7 July 2022 to 29 September 2022.

A large range of biosimilars of the anti-inflammatory drug Humira (adalimumab) are expected to flood the market in 2023. There could be as many as 10+ biosimilar competitors on the market by the end of 2023, based on current US Food and Drug Administration (FDA) approvals and pending applications [1].