Biosimilars

FDA approves aflibercept biosimilars Enzeevu and Pavblu

Biosimilars/News | Posted 15/10/2024

The US Food and Drug Administration (FDA) has approved two more aflibercept biosimilars in August 2024. The FDA granted approval for Sandoz’s Enzeevu (aflibercept-abzv) and Amgen’s Pavblu (aflibercept-ayyh) on 12 and 23 August 2024, respectively, making them the fourth and fifth approvals for a biosimilar referencing Eylea.

Innovative direct purchase agreement sees adalimumab biosimilar prices slashed

Biosimilars/General | Posted 15/10/2024

On 1 October 2024, Blue Shield of California in the US announced that it will pay far less for an adalimumab biosimilar. The transparent net price paid by the health plan provider will be US$525 per monthly dose, compared to the market-reported net price of reference product Humira at US$2,100.

EC approvals of four biosimilars: Tofidence, Wezenla, Avzivi and SteQeyma

Biosimilars/News | Posted 08/10/2024

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

Biosimilars/General | Posted 08/10/2024

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

Biosimilars/News | Posted 01/10/2024

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/General | Posted 01/10/2024

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

Biosimilars/News | Posted 24/09/2024

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

Biosimilars/Research | Posted 24/09/2024

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

Biosimilars/News | Posted 18/09/2024

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

Biosimilars/General | Posted 18/09/2024

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].