Biosimilars

China approves first denosumab copy biological Maiweijian

Biosimilars/News | Posted 16/04/2024

On 3 April 2024, China-based biopharmaceutical company Mabwell announced that their Maiweijian (denosumab) injection, developed by its wholly owned subsidiary T-mab, obtained the marketing approval from China’s National Medical Products Administration (NMPA). This product is the first denosumab copy biologicalto receive marketing approval in China.

Addressing the persistent gap in Medicare access to Humira biosimilars

Biosimilars/General | Posted 16/04/2024

In an article by Dr Joshua Cohen, he discusses the challenges facing the adoption of biosimilars in the US, particularly focusing on Medicare beneficiaries' access to these lower-cost alternatives to brand-name biologics like Humira.

Topline results for Polpharma Biologics’ vedolizumab biosimilar candidate

Biosimilars/Research | Posted 16/04/2024

In February 2024, Polpharma Biologics (Polpharma) unveiled topline results demonstrating the PK and pharmacodynamic (PD) comparability of PB016, their biosimilar candidate for vedolizumab, with its reference drug, Entyvio, by Takeda Pharmaceutical.

EMA recommends approval of first denosumab biosimilar Jubbonti and Wyost

Biosimilars/News | Posted 09/04/2024

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

Biosimilars/News | Posted 03/04/2024

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

Biosimilars/Research | Posted 03/04/2024

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

Biosimilars/Research | Posted 27/03/2024

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

Biosimilars/News | Posted 27/03/2024

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

Biosimilars/News | Posted 22/03/2024

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

Biosimilars/Research | Posted 22/03/2024

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

Biosimilars/News | Posted 11/03/2024

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

Biosimilars/Research | Posted 07/03/2024

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

Biosimilars/News | Posted 07/03/2024

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

Biosimilars/News | Posted 29/02/2024

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

Biosimilars/General | Posted 09/02/2024

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

Biosimilars/News | Posted 06/02/2024

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

Biosimilars/General | Posted 06/02/2024

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

Biosimilars/News | Posted 30/01/2024

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.

CVS Caremark removes Humira in the US and Sandoz launches Hyrimoz in Europe

Biosimilars/General | Posted 30/01/2024

It has been announced that the US’ CSV Caremark, a CVS Health company and one of the country’s largest pharmacy benefit managers (PBMs), will remove AbbVie’s Humira (adalimumab), from its major national commercial formularies effective 1 April 2024, in favour of biosimilar options. In Europe, Sandoz has launched its biosimilar Hyrimoz (adalimumab), a citrate-free high-concentration formulation (HCF) indicated for all conditions of the reference medicine.

EC approval of trastuzumab biosimilar Herwenda

Biosimilars/News | Posted 23/01/2024

The European Commission (EC) granted marketing authorization for trastuzumab biosimilar Herwenda on 15 November 2023. The biosimilar of Herwenda is developed by EirGenix, Inc.