Biosimilars
EMA recommends approval of ustekinumab biosimilar Pyzchiva
On 22 February 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Pyzchiva (ustekinumab), a biosimilar of reference product Stelara.
ANVISA's role in biosimilar medicine regulation and innovation promotion
The focus of the study by Vilha et al. [1] was to comprehend the role of the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária (ANVISA), not only as a regulatory authority but also as a catalyst for technological development and innovation. ANVISA has implemented a significant change in the way health regulations are handled in Brazil.
FDA approves interchangeable adalimumab biosimilar Simlandi
On 23 February 2024, the US Food and Drug Administration (FDA) approved Alvotech and Teva’s Simlandi (adalimumab-ryvk) injection as an interchangeable biosimilar to AbbVie’s Humira (adalimumab).
Infliximab discontinuation in patients with originator retransition vs biosimilar continuation
A study by Meijboom et al. aimed to compare the risk of and reasons for infliximab discontinuation between retransitioned patients and those remaining on biosimilar [1].
EC approval of ranibizumab biosimilar Rimmyrah
The European Commission (EC) granted marketing authorization for ranibizumab biosimilar Rimmyrah on 5 January 2024. The biosimilar was developed by Qilu Pharma.
FDA BLA updates from Celltrion and Accord
In January 2024, Celltrion submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for CT-P47, a biosimilar candidate of the reference product Actemra ( tocilizumab). In addition, Accord BioPharma, announced that the FDA accepted its BLA for DMB-311, a biosimilar to Stelara (ustekinumab), approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
Brazil advances in follow-on biologicals/biosimilars approvals, trailing Europe
Brazil is the fourth-largest market in terms of approved follow-on biological medications worldwide. As of May 2023, Brazil has approved 52 follow-on biological medicines [1] and approximately 30 biological products awaiting testing or already being tested by the Brazilian Health Regulatory Agency, ANVISA (Agência Nacional de Vigilância Sanitária) [2].
FDA approves pegfilgrastim biosimilar Udenyca OnBody autoinjector
On 26 December 2023, Coherus BioSciences announced the US Food and Drug Administration’s (FDA) approval of Udenyca OnBody, an on-body injector (OBI) presentation of Udenyca (pegfilgrastim-cbqv), a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.
Insurer perspective on increasing biosimilar uptake in Canada
In November 2023, Canada’s Prince Edward Island (PEI) became the 11th Canadian jurisdiction to announce the adoption of biosimilars switching policies [1-10]. This follows the trend in Canada, to try to increase the uptake of biosimilars.
FDA approves bevacizumab biosimilar Avzivi
On 6 December 2023, the US Food and Drug Administration (FDA) approved China–based manufacturer Bio-Thera Solutions’ bevacizumab biosimilar (BAT1706), Avzivi (bevacizumab-tnjn). This product will be marketed globally by Sandoz.
