Biosimilars
EC approvals of four biosimilars: Tofidence, Wezenla, Avzivi and SteQeyma
The European Commission (EC) granted marketing authorization for four biosimilars between June and August 2024. In August 2024, the EC approved Celltrion’s SteQeyma (ustekinumab), in July 2024, Bio-Thera’s Avzivi (bevacizumab), and in June 2024, Amgen’s Wezenla (ustekinumab) and Biogen/Bio-Thera’s Tofidence (tocilizumab).
Stelara biosimilar available at US$0 for Accredo patients
On 5 September 2024, Evernorth Health Services in the US announced that a biosimilar of Johnson and Johnson’s Stelara (ustekinumab) will be available for US$0 out of pocket for eligible patients of its specialty pharmacy, Accredo.
Canada approves trastuzumab Adheroza and ustekinumab Steqeyma biosimilars
In August 2024, Henlius Biotech's trastuzumab biosimilar, Adheroza, received marketing approval from Health Canada. In July 2024, Celltrion’s ustekinumab biosimilar, Steqeyma (CT-P43), also gained Health Canada approval.
Ten best-selling biosimilars in Brazil in 2023
Biosimilars experienced a notable increase in sales during 2023, according to a study published by the Brazilian Association of Generic and Biosimilar Drug Industries (PróGenéricos). The data reveal that about 892,000 units of biosimilars were sold, representing a 43% growth compared to 2022.
EMA recommends approval of ranibizumab, rituximab and trastuzumab biosimilars
On 25 July 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 three more monoclonal antibody biosimilars: ranibizumab, rituximab, and trastuzumab.
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.
