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Commission (FTC) said yesterday that it has submitted a comment supporting the Food and Drug Administration’s (FDA) draft guidance regarding interchangeable biosimilar drugs. 23 August 2024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
YL Biologics (YLB) has announced that a Phase III clinical trial of its investigational Enbrel (etanercept) biosimilar YLB113 has met its primary endpoint. 9 February 2018
Californian life sciences firm BioSciencesCorp has partnered with Shanghainese CMO Mab-Venture, to develop and manufacture multiple undisclosed biosimilars for emerging markets. 9 February 2018
Pfizer’s manufacturing partner in South Korea Celltrion has received a warning letter from the US FDA after an inspection of its Incheon-based facility uncovered “issues related to certain manufacturing processes.” 7 February 2018
While the likes of Amgen and Johnson & Johnson have already started to take the hit from competitors to big-selling biologics, looking ahead to the next two to three years, it is unlikely that the specter of biosimilars hangs over any company more than Roche. 5 February 2018
Korean biosimilar company Samsung Bioepis is making a habit of presenting data on its products that shows that they not only compare with the original, but could actually be superior to the reference drug. 29 January 2018
US pharma giant Pfizer could be yet another contender in the growing number of biosimilar copies of Roche’s blockbuster cancer drug Rituxan/MabThera (rituximab). 24 January 2018
A research note from Samsung Bioepis, accepted for publication in the British Journal of Dermatology, suggests the firm’s etanercept biosimilar may be less immunogenic than the reference product Enbrel, produced by Amgen. 23 January 2018
Positive results of the Phase III study for JR-131, a proposed biosimilar to darbepoetin alfa, a long-acting erythropoiesis-stimulating agent for the treatment of renal anemia, have been announced by Japanese drugmakers Kissei Pharmaceutical and JCR Pharmaceuticals. 19 January 2018
Sandoz, Swiss pharma giant Novartis’ generics and biosimilars business, has signed a global partnership with Indian drugmaker Biocon, to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide. 18 January 2018
Sandoz, the biosimilars and generics division of Swiss pharma giant Novartis, says that the US Food and Drug Administration has accepted its Biologics License Application (BLA), submitted under the 351 (k) pathway, for proposed biosimilar adalimumab to the reference medicine, Humira. 16 January 2018
A New Year report from CPhI forecasts 2018 will be a transformative year for Japanese pharma as the market evolves towards growth in generics, biosimilars and increased internationalization. 15 January 2018
The first biosimilar version of Roche’s blockbuster Herceptin (trastuzumab) has been approved in Brazil by ANVISA, the country’s medicines regulatory agency. 29 December 2017
Jordanian drugmaker Hikma Pharmaceuticals now has exclusive rights to sell a biosimilar of Rituxan/MabThera (rituximab) in the Middle East and North Africa (MENA) after agreeing a deal with South Korean biopharmaceutical firm Celltrion. 19 December 2017
The US Food and Drug Administration (FDA) has approved Pfizer’s (NYSE: PFE) biosimilar drug Ixifi (infliximab-qbtx), which references the big-selling inflammatory diseases drug Remicade. 14 December 2017
The US Food and Drug Administration has approved Admelog (insulin lispro injection), the first follow-on (ie, a similar) insulin lispro to help people living with diabetes manage blood sugar levels at mealtime. 12 December 2017
Russian biotech and biosimilars company Biocad is launching production in North Africa. As part of these plans, the company will start manufacturing of anti-cancer drugs at the facilities of the Moroccan pharmaceutical company SothemaLabs, reports The Pharma Letter’s local correspondent. 29 November 2017
Indian biotech firm Biocon has launched Krabeva, a biosimilar bevacizumab for the treatment of patients with metastatic colorectal cancer and other types of lung, kidney, cervical, ovarian and brain cancers, in India. 24 November 2017
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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.