Pharma News
Top 10 most read GaBI Online articles in 2020
This article reviews some of the most important events for biosimilars during 2020. For biosimilars these included the World Health Organization’s (WHO) prequalification of its first biosimilar and US Food and Drug Administration (FDA) rules and guidance. Other subjects of interest for biosimilars were European Medicines Agency (EMA) approvals, the biosimilars market in Latin America, biosimilar litigation, and extrapolation, immunogenicity, switching and substitution of biosimilars.
Celltrion: Takeda acquisitions and new plant development
Celltrion completed the acquisition of selected primary care assets from Takeda Pharmaceutical Company Limited in the Asia Pacific region in November 2020. In addition, the company announced it will be building a new biopharmaceutical plant and a global biotechnology research centre in Songdo, Incheon, South Korea.
Momenta to reduce its biosimilars programmes
US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 1 October 2018 that it would be focusing on two key biosimilars and quit the development of five others.
New Alvotech partnerships in South Africa and China
Iceland-based biopharmaceutical company Alvotech entered into two partnerships in November 2020, that will expand their reach into South Africa and China.
AffaMed and EverInsight merger announced
AffaMed Therapeutics announced a merger agreement with EverInsight Therapeutics on 10 October 2020.
Essex and Henlius collaborate to deliver bevacizumab biosimilar for ophthalmic diseases
On 15 October 2020, it was announced that two Essex Bio-Technology subsidiaries were entering an agreement with Shanghai Henlius Biotech. Under this, Essex Bio-Investment and Zhuhai Essex Bio-Pharmaceuticals will work with Henlius to co-develop a bevacizumab biosimilar for the treatment of ophthalmic diseases.
Medicure and Reliance sign cardiovascular drug agreement
Medicure Inc announced on 5 October 2020 that it has entered a License, Manufacture and Supply Agreement with Reliance Life Sciences Private Limited (RLS) for a cardiovascular drug. Under this agreement, Medicure is responsible for the regulatory approval process for the drug product and is granted the exclusive right to market and sell it in Canada, European Union and the US. The cardiovascular drug is currently unnamed.
Aurobindo and Huons refocus their biologicals/biosimilars portfolios
India-based generics maker Aurobindo Pharma (Aurobindo) has announced a renewed product focus and plans for the biosimilars of its subsidiary company. In addition, Korea-based Huons will collaborate with Singapore-based Prestige BioPharma’s (Prestige) to enter the biosimilars market.
Lotus to distribute CKD’s biosimilar darbepoetin alfa in South East Asia
On 18 September 2020, Taiwan-based Lotus Pharmaceutical Co (Lotus) announced a long-term collaboration with Korea-based Chong Kun Dang Pharmaceutical Corp (CKD) for the distribution of biosimilar darbepoetin alfa (CKD-1110) in South East Asia.
Henlius and Accord collaborations will see their trastuzumab biosimilar launch globally
On 30 September 2020, Accord Healthcare (Accord) and Shanghai Henlius Biotech announced that they are to enter a new collaboration. As part of their agreement, Henlius will grant an exclusive licence to Accord US to develop and commercialize their trastuzumab biosimilar in Canada and the US. This follows the June 2018 Henlius‒Accord UK licence agreement, under which Henlius granted Accord UK exclusive commercialization rights of HLX02 trastuzumab. This led the product being approved by the European Commission in July 2020 [1] and its UK launch on 24 September 2020.
