Biosimilars
EMA recommends approval of first denosumab biosimilar Jubbonti and Wyost
On 21 March 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Sandoz’s medicinal products, Jubbonti and Wyost (denosumab), which are biosimilars of Amgen’s reference products Prolia and Xgeva, respectively.
First denosumab biosimilars approved in Canada and the US
The first and only denosumab biosimilars for osteoporosis and increasing bone mass were approved in Canada and the US in February and March 2024.
Comparing biosimilar adoption: Medicare Advantage versus traditional Medicare
Biosimilar products, vital for widening access to essential treatments and reducing healthcare costs, face varied uptake influenced by factors like pricing and healthcare settings. Kozlowski et al.'s study compares adoption rates in Medicare Advantage (MA) and Traditional Medicare (TM), revealing significant differences [1].
Questioning the need for ethnic sensitivity assessments for biosimilar monoclonal antibodies
A GaBIJ perspective article entitled ‘Ethnic sensitivity assessments in biosimilar monoclonal antibodies clinical development programmes: necessary or not?’, was published by a group of authors from Biocon Biologics in August 2023 [1].
Dr Reddy's launches bevacizumab biosimilar Versavo in the UK
On 19 March 2024, Dr Reddy’s Laboratories announced that it would be launching Versavo, a bevacizumab biosimilar, in the UK.
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.
