Biosimilars
Long-term real-world safety experience of biosimilars confirms concept of biosimilarity
A review by Sagi S, et al. highlighted that biological medicines are well established in clinical practice for the treatment of many serious and chronic conditions [1].
COFEPRIS approves bevacizumab Bhava and trastuzumab Mamitra biocomparables
In July 2024, the Mexican regulatory authority COFEPRIS (Federal Commission for the Protection Against Sanitary Risk, Comisión Federal para la Protección contra Riesgos Sanitarios), approved two biocomparables – bevacizumab Bhava and trastuzumab Mamitra – from India-based Zydus.
International biosimilars players expanding their presence in China
The market for copy biologicals in China has significantly grown over the past decade. By early 2022, over 60 pharmaceutical companies were involved in the development of copy biological products [1].
EMA recommends approval of four ustekinumab biosimilars: Eksunbi, Fymskina, Otulfi, Steqeyma
On 25 July and 27 June 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of marketing authorization for four ustekinumab biosimilars.
Boehringer and GoodRx make Humira biosimilar available at 92% discount
On 18 July 2024, it was announced that Boehringer Ingelheim (Boehringer) and GoodRx, the leading prescription savings platform in the US, launched a patient affordability initiative. From now on, Boehringer's citrate-free adalimumab-adbm, a biosimilar to Humira (adalimumab), will be available at a 92% discount to the list price of the AbbVie originator drug, exclusively on GoodRx.
FDA approves filgrastim biosimilar Nypozi
In addition to the biosimilars approval of Pyzchiva (ustekinumab-ttwe), with a provisional determination for interchangeability designation [1], and Ahzantive (aflibercept-mrbb) [2] on 28 June 2024, the US Food and Drug Administration (FDA) also approved Tanvex BioPharma’s Nypozi (filgrastim-txid) biosimilar, which references Amgen’s Neupogen.
Budget impact analysis of Rixathon introduction in Chile for non-Hodgkin lymphoma
Non-Hodgkin lymphoma (NHL) is a significant global health concern, with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) being the most prevalent subtypes. In Chile, treatment for DLBCL and FL is covered by the public healthcare system, primarily using rituximab-based therapies. The recent introduction of rituximab biosimilars, such as Rixathon, presents a potential for cost savings in the healthcare system.
FDA approves third aflibercept biosimilar Ahzantive
The US Food and Drug Administration (FDA) was busy in June 2024. On 28 June 2024, the FDA granted approval for Formycon’s Ahzantive (aflibercept-mrbb), making it the third approval for a biosimilar referencing Eylea.
Biosimilars in inflammatory bowel disease: are we ready for multiple switches
A review by Teixeira FV et al. discusses whether scientific evidence is sufficient to support multiple switches between biologicals and biosimilars in patients with inflammatory bowel diseases (IBD) [1].
Richmond to launch similar biologicals bevacizumab Yriviak and adalimumab Armixa
On 22 July 2024, the Argentina-based Laboratorios Richmond announced the launch of Yriviak, a bevacizumab similar biological, in Argentina. In the coming months, Richmond plans to launch their adalimumab similar biological, Armixa.
