3 October 2024 F2G’s September $100m funding round provides the company with crucial funds to
renavigate approval of its lead drug, olorofim. The substantial financing also
highlights the paucity of novel antifungal products in the clinic.
Israel’s Teva Pharmaceutical Industries and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, have announced a global licensing deal for the development of an anti PD-1 oncology biosimilar candidate. 3 October 2024
The Biosimilars Council, alongside the Association for Accessible Medicines (AAM), released its 2024 US Generic & Biosimilar Medicines Savings Report. 6 September 2024
Biosimilar-focused biopharmaceutical company and contract development and manufacturing organization (CDMO) Tanvex BioPharma has named Stephen Lam its new chief executive (CEO). 5 September 2024
Biocon Biologics has signed a settlement and license agreement with Johnson & Johnson that clears the way to commercialize its Bmab 1200, a proposed biosimilar to Stelara (ustekinumab), in Europe, the UK, Canada, and Japan. 3 September 2024
Regeneron Pharmaceuticals has filed a lawsuit against Sandoz, alleging that its biosimilar to Eylea (aflibercept) infringes certain patents. 29 August 2024
Celltrion’s US subsidiary has signed an agreement with pharmacy benefit managers (PBMs) Cigna Healthcare, and Express Scripts that will help expand patient access to Zymfentra (infliximab-dyyb). 29 August 2024
Drug development consultancy Certara has published a report on the Inflation Reduction Act’s (IRA) impact on oncology biosimilar uptake. 29 August 2024
South Korea’s Celltrion yesterday announced the European Commission (EC) approval for the use of SteQeyma (CT-P43), an ustekinumab biosimilar referencing Stelara, for the treatment of multiple chronic inflammatory diseases. 27 August 2024
The USA’s Federal Trade Commission (FTC) said yesterday that it has submitted a comment supporting the Food and Drug Administration’s (FDA) draft guidance regarding interchangeable biosimilar drugs. 23 August 2024
The US subsidiary of South Korea’s Celltrion announced its US Food and Drug Administration (FDA)-approved biosimilar adalimumab-aaty has been added to the Costco member prescription program. 14 August 2024
The US Food and Drug Administration (FDA) has approved Enzeevu (aflibercept-abzv) 2mg vial kit and pre-filled syringe for intravitreal injection, developed by Swiss biosimilars company Sandoz. 12 August 2024
The Biosimilars Council—part of the USA’s Association for Accessible Medicine (AAM) representing companies developing off-patent medicines—has provided an update on its activities on the regulatory, legislative and educational fronts. 5 August 2024
Chinese biotech Bio-Thera Solutions (SHSE: 688177) has picked up European Medicines Agency approval for BAT1706, a biosimilar referencing Avastin (bevacizumab). 1 August 2024
The US Food and Drug Administration (FDA) has issued a Federal Register notice, “Biosimilar Product Development Guidance; Establishment of a Public Docket; Request for Information and Comments.” 25 July 2024
Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products. 23 July 2024
The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) submitted by South Korea’s Samsung Bioepis for Epysqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab). 22 July 2024
Celltrion has agreed to partner for the development of novel ADCs against validated antibody targets, including HER21 and CD202 with Canada-based iProgen Biotech. 8 April 2019
The changing intellectual property (IP) landscape for pharmaceuticals was debated at the Legal Affairs Conference in held today in Amsterdam by Medicines for Europe, the lobbying group for biosimilars and generic drugmakers. 27 March 2019
The UK’s Competition and Markets Authority (CMA) has closed its investigation into a questionable discount scheme introduced to the National Health Service (NHS) by American pharma giant Merck & Co. 15 March 2019
Russian‘s leading drugmaker Biocad has registered a biosimilar of Humira (adalimumab), the world’s best-selling drug, used for the treatment of rheumatoid arthritis and psoriasis, among other inflammatory conditions, according to the company. 15 March 2019
Richard Francis will be stepping down as chief executive of Sandoz, the Novartis generics and biosimilars division, and as a member of the executive committee of Novartis on March 31, 2019. 14 March 2019
The US Food and Drug Administration has approved Trazimera (trastuzumab-qyyp), a biosimilar to Herceptin (trastuzumab), for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. 12 March 2019
“We're at a critical point for the future of biosimilars in the US. Millions of American patients stand to benefit from increased utilization of these lower-cost, high-quality products,” US Food and Drug Commissioner Scott Gottlieb declared on Thursday. 8 March 2019
A woman who has been involved in biosimilars since work on their development first began two decades ago, has been named director general of the International Generic and Biosimilar medicines Association (IGBA). 21 February 2019
The Canadian Competition Bureau announced yesterday that it is closing an investigation into allegations of abuse of dominance by Janssen, a Canadian subsidiary of US healthcare giant Johnson & Johnson. 21 February 2019
South Korea’s Samsung Bioepis, a joint venture between the Korean conglomerate Samsung and US biotech Biogen, has said it is expanding in mainland China through a licensing agreement with C-Bridge Capital. 11 February 2019
Following European Commission approval last November, the Mundipharma network of independent associated companies today announced the launch of Pelmeg (pegfilgrastim). 6 February 2019
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) today announced that it has recommended six new medicines following its January 28-31 meetings. 1 February 2019
Medicines for Europe, a trade group representing the generic and biosimilar industries across Europe, has welcomed a vote in the European Parliament supporting a comprehensive SPC manufacturing waiver. 23 January 2019
Privately-held Icelandic biopharmaceutical company Alvotech announced today that it has successfully raised $300 million through a private bond offering. 22 January 2019
The US Food and Drug Administration on Friday approved South Korean firm Samsung Bioepis’ Ontruzant (trastuzumab-dttb), a biosimilar trastuzumab referencing Herceptin, for the treatment of HER2-positive breast cancer and HER2 over-expressing gastric cancer. 19 January 2019
As a draft regulation to introduce a manufacturing waiver to the protection granted by a supplementary protection certificate (SPC) moves closer in Europe, drug industry lobby groups show no sign of backing down on their positions. 17 January 2019
At the JP Morgan Healthcare Conference in San Francisco, South Korea’s Celltrion outlined details of its business plan for 2019, confirming the firm’s main focus will be on the development of a subcutaneous form of CT-P13, a biosimilar version of the immunological therapy infliximab. 10 January 2019
Following on from its successful commercialization deals with Biogen and Merck & Co in Europe and the USA, a major player in the burgeoning biosimilar space has made its move into another massive market. 7 January 2019
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Company Spotlight
A pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases.