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.
On Friday morning, a judgment was handed down in the hard-fought litigation between Japan’s Fujifilm Kyowa Kirin Biologics (FKB) and the USA’s AbbVie. 4 March 2017
Leading Russian biotech and biosimilars firm Biocad will invest 20 billion roubles ($340 million) in production facilities in St Petersburg over the next three to five years, with significant support from the public sector. 28 February 2017
Last week saw a bit of catch up on year-end financial results reporting from European drugmakers, including Belgium’s UCB, France’s Ipsen and Germany’s Bayer. 26 February 2017
An industry trade group representing manufacturers of generic and biosimilar products has urged the US Supreme Court not to grant biotech firms an extra six months of patent exclusivity. 23 February 2017
Truxima (biosimilar rituximab) has been approved by the European Medicines Agency for use in all indications of the reference product Mabthera, the blockbuster monoclonal antibody developed by Roche. 22 February 2017
Trade group Medicines for Europe says it welcomes the approval by the European Parliament of the European Union and Canada Comprehensive Economic and Trade Agreement (CETA) that can be an opportunity for medicine manufacturers in the two regions. 22 February 2017
Biocad and R-farm, the exclusive distributor for Swiss pharma giant Roche, continue their legal battles in Russia regarding the sale of Roche’s blockbuster cancer drug Herceptin (trastuzumab) and a biosimilar produced by Biocad. 21 February 2017
South Korean biopharmaceutical firm Celltrion has presented the primary outcome from its pivotal randomized controlled trial of CT-P13, a Remicade (infliximab) biosimilar branded as Remsima and Inflectra, in Crohn’s disease. 17 February 2017
Netherlands-based generics major Mylan and Indian drugmaker Biocon have had their Biologics License Application (BMA) for a second biosimilar accepted by the US Food and Drug Administration (FDA). 16 February 2017
The Generic Pharmaceutical Association (GPhA), the USA’s largest trade group representing generic pharmaceutical and biosimilar companies, has rebranded itself as the Association for Accessible Medicines (AAM). 15 February 2017
Dr Nicola Davies explores how pharma companies can secure the future of biobetters in the presence of biosimilars and increased payer scrutiny on high prices. 14 February 2017
This week, Medicines for Europe engaged alongside its Irish national association Health Enterprise Alliance (HEA) in illustrating the benefits of stimulating competition in the biologic medicines market in Ireland. 10 February 2017
Shares in biotech firm Kyowa Hakko Kirin were up 3.9% at 1,581 Yen ($14) today on news that the Japanese drugmaker has founded a new biosimilars firm, Kyowa Kirin Frontier. 1 February 2017
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eight medicines for approval at its January meeting. 28 January 2017
Russia’s leading biotech firm Biocad is finishing clinical trials of a new anti-cancer drug that will soon appear in the Russian market and will be able to compete with imported analogues. 25 January 2017
Swiss pharma giant Novartis’ subsidiary Sandoz might have received US approval for Erelzi, a biosimilar to US biotech major Amgen’s Enbrel (etanercept), in August 2016, but it will not go on sale until 2018 at the earliest. 25 January 2017
Privately-held Swiss firm Ewopharma has signed an agreement to market and sell anti-tumor necrosis factor (anti-TNF) biosimilars of Enbrel (etanercept) and Remicade (infliximab) in Central Eastern Europe. 23 January 2017
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
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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.