In January 2023, Alvotech announced that it has initiated of a pharmacokinetic study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab). In addition, Dr Reddy’s Laboratories Ltd announced the successful completion of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI. This is now ready for filing in markets such as the US and Europe.

A recent paper by Barbier et al. described the criteria to be considered when selecting best-value biological, emphasizing that more factors should be taken into account than only the price, and the authors proposed an updated approach - a model, and guidelines to assist healthcare professionals to make transparent and evidence-based decisions [1].

In the US it has been announced that several pharmacy benefit managers (PBMs) will be adding multiple biosimilar versions of AbbVie’s Humira (adalimumab) to their formularies in 2023.

A study on the estimation of patients with rheumatoid arthritis (RA) as well as those patients who are potentially eligible for the treatment of the disease with biological drugs, was presented by Luca Degli Esposti of CliCon Società Benefit Italy at the 18th Biosimilar Medicines Conference in October 2022.

In Germany and Switzerland, more biosimilars were marketed and at lower prices than in the US between 2011 and 2020, finds a JAMA Network Open article [1].

The US Food and Drug Administration (FDA) awarded Eli Lilly’s Rezvoglar, an  insulin glargine biosimilar, the interchangeable designation in late 2022. This means that in the US, Rezvoglar can now be substituted at the pharmacy level for the originator, Sanofi’s Lantus, without a doctor’s prescription, provided state pharmacy law permits the switch. In addition, a study revealed that Pfizer’s  adalimumab biosimilar may also soon achieve this status.

In late 2022 and early 2023, Alvotech announced several strategic partnership advances to further their global reach as a biotech company specializing in the development and manufacture of biosimilar medicines.

The US introduced the Biologics Competition Act of 2022 (HR 887) in September 2022. This was followed by the introduction of the Biosimilar Red Tape Elimination Act in November 2022. Both acts seek to make biosimilar products more accessible and increase their uptake in the US.

The Canadian province of Ontario is the latest to introduce a biosimilars switching policy. Under the terms of the policy, Ontario Drug Benefit (ODB) recipients who are on an originator biological will be required to transition to a Health Canada approved biosimilar version of the drug.

Alvotech and Teva Pharmaceuticals announced in January 2023, that the US Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for AVT04, Alvotech’s proposed biosimilar to Stelara® (ustekinumab). Meanwhile, Biocon Biologics received a complete response letter (CRL) from FDAregarding its application for an insulin aspart biosimilar (filed by its partner Viatris).