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Commission (FTC) said yesterday that it has submitted a comment supporting the Food and Drug Administration’s (FDA) draft guidance regarding interchangeable biosimilar drugs. 23 August 2024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
Pharma giant Merck & Co on Tuesday raised its outlook for full-year profit while posting a second-quarter earnings ahead of estimates despite a drop in sales. 29 July 2015
Japan’s Fujifilm Kyowa Kirin Biologic has entered into an agreement with Anglo-Swedish pharma major AstraZeneca to establish a joint venture for the development and commercialization of FKB238 in development for the treatment of multiple solid tumors. 27 July 2015
The US Court of Appeals for the Federal Circuit has rejected arguments by US biotech major Amgen that Novartis failed to properly follow regulations when it sought to launch Zarxio (filgrastim-sndz). 22 July 2015
South Korea’s Samsung Bioepis says that its pivotal Phase III clinical study of SB5, an investigational biosimilar of AbbVie’s Humira (adalimumab), met its primary endpoint. 18 July 2015
A new report from RnRMarketResearch, Japan Pharma Outlook 2015: 2015 -Year to Watch out for Authorized Generics, Biosimilars and Overseas Strategic Initiatives, says most of the companies are revalidating their domestic (and thus overseas) strategies to adapt to new regulations. 16 July 2015
South Korea’s Celltrion has received approval to sell its Remsima from the Ministry of Health of the Russian Federation (Minzdrav) on July 13, reported BusinessKorea. 15 July 2015
USA-based Epirus Biopharmaceuticals and Polpharma Group, Poland’s largest drugmaker, have signed a multi-product, multi-region profit-sharing collaboration for select Epirus biosimilars. 14 July 2015
France-headquartered Sartorius Stedim Biotech (SSB), a leading international supplier for the pharma and biotech industries, has acquired Cellca GmbH based in Laupheim, Germany. 3 July 2015
The Biosimilars Council, a division of the USA's Generic Pharmaceutical Association has joined the call to maintain the currently accepted international nonproprietary naming system. 2 July 2015
The global biosimilars market value is expected to reach $20 billion by the end of 2015 and could hit $55 billion by 2020, with growth primarily driven by a promising pipeline in active development and government efforts to reduce health care spending, new research indicates. 1 July 2015
South Korea’s Samsung Group is considering taking its biotech affiliate Samsung Bioepis public in the USA, according to a report by the Korea Economic Daily. 30 June 2015
The last-minute decision by Australia’ Health Minister Sussan Ley to abandon a Strategic Agreement casts a shadow over the future stability of the local medicines industry and also puts patient safety at risk, says trade group Medicines Australia. 23 June 2015
The decision announced on Friday by the Australian government that would allow clinicians and pharmacists to give patients themselves the option of substituting cheaper biosimilar version of a biological medicines (The Pharma Letter June 19) has come in for a great deal of criticism, both locally and more vociferously in the USA. 20 June 2015
Australia’s independent Pharmaceutical Benefits Advisory Committee (PBAC) has made a world-first recommendation to allow clinicians and pharmacists to give patients the option of substituting expensive biologic medicines at the chemist if there is a cheaper replacement or ‘biosimilar’ available that has been determined by experts to be a safe, equally-effective treatment. 19 June 2015
Indian company Intas Pharmaceuticals has launched Razumab in India, its biosimilar to Lucentis (ranibizumab), from Genentech, a wholly-owned subsidiary of Roche. 19 June 2015
US Representative Steve Stivers (Republican, Ohio) yesterday joined Rep Peter Welch (Democrat, Vermont) to re-introduced the Fair Access for Safe and Timely (FAST) Generics Act to increase consumer access to generic drugs, boost market competition and ultimately save consumers money. 19 June 2015
US biotech firm Biogen and its South Korean joint venture Samsung Bioepis today released positive results from their anti-TNF biosimilar portfolio are being presented at the European League Against Rheumatism Annual Congress (EULAR 2015) in Rome, June 10–13, 2015. 10 June 2015
The European Investment Bank (EIB) is lending 45 million euros (around $50.7 million) to the largest Polish manufacturer of pharmaceuticals, Polpharma, for its research into and development of biosimilar drugs – more affordable alternatives to current treatments. 4 June 2015
There are substantial opportunities across Turkey and neighboring markets, according to the Pharma Insights Turkey 2015 report which was compiled with all major Turkish pharma manufacturers. 3 June 2015
Hospira says its partner, South Korea’s Celltrion, has received approval from ANVISA, the National Health Surveillance Agency in Brazil, for Remsima (infliximab). 3 June 2015
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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.