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.
A US Food and Drug Administration advisory committee has unanimously recommended approval of a biosimilar version of the big-selling arthritis drug Enbrel (etanercept). 14 July 2016
The Arthritis Advisory Committee of the US Food and Drug Administration has unanimously recommended approval of ABP 501, a biosimilar being developed by US biotech Amgen, which references Humira (adalimumab), an arthritis drug marketed by US pharma major AbbVie. 13 July 2016
A wave of expiring biotech patents will lead to a surge in growth for manufacturers of biosimilars during the coming years, notes Bellevue Asset Management's healthcare team. 13 July 2016
Patient access to biosimilar medicines will hinge on critical policy decisions around extrapolation and biosimilar label content, asserts the Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA) in comments to the Food and Drug Administration’s Arthritis Advisory Committee. 13 July 2016
A biosimilar version of Pfizer and Amgen’s arthritis drug Enbrel is ‘highly similar’ to the reference product, according to US Food and Drug Administration (FDA) staff briefing documents. 12 July 2016
The non-profit AIDS Healthcare Foundation (AHF) will appeal the dismissal of its federal lawsuit against US biotech major Gilead Sciences and other defendants alleging drug patent manipulation and anti-trust claims relating to slightly different formulations of the HIV drug tenofovir. 12 July 2016
Sagent Pharmaceuticals saw its shares leap nearly 42% to $22.006 in pre-market trading today, after Japan’s Nichi-Iko Pharmaceutical revealed it was planning to buy the company. 11 July 2016
Selexis and Turgut Ilaclari have entered into a service agreement that provides Turgut with access to Selexis SUREtechnology Platform and SURE CHO-M Cell Line for the development of quality biosimilar products. 11 July 2016
A biosimilar version of the world’s best-selling drug is ‘highly similar’ to the reference product, according to a US Food and Drug Administration staff briefing documents published ahead of tomorrow’s committee meeting. 11 July 2016
Sandoz, the generics and biosimilars division of Swiss pharma giant Novartis, has released results from the EGALITY trial in which the primary endpoint of achieving equivalence in Psoriasis Area and Severity Index (PASI) 75 response rates at week 12 was met. 9 July 2016
Knowing when to prescribe biosimilars is a massive issue internationally, and action is being taken on the issue in the UK to make sure they are used appropriately and in consultation with patients. 8 July 2016
Cipla this week said it is planning to invest 1.3 billion rupees ($19.3 million) into South Africa's first state-of-the-art biotech manufacturing facility through its biotech subsidiary for the production of biosimilars. 8 July 2016
The US Court of Appeals for the Federal Circuit on Tuesday affirmed a district court’s ruling that a biosimilar applicant must provide a reference product sponsor with 180 days’ notice before commercial marketing of a biosimilar begins, regardless of whether the applicant provided notice of US Food and Drug Administration review. 8 July 2016
The highly mature type 2 diabetes (T2D) market, which is forecast to be valued at $58.7 billion by 2025, will see pharmaceutical companies prioritizing competitive pricing in order to offset the impact of patent expiries ahead of improving existing products, new research indicates. 7 July 2016
After a series of hearings, the Court of Appeals of Sri Lanka has finally dismissed the claims from Swiss pharma giant Roche (ROG: SIX) in a lawsuit seeking to stop distribution of the Russian-made anti-tumor biosimilar products, as well as seeking to revoke Biocad’s product market authorization in Sri Lanka for the anti-cancer drugs trastuzumab and bevacizumab. 5 July 2016
Gedeon Richter says it has acquired Finox Holding, a privately held Swiss biotech company focused on development and commercialization of innovative and cost effective products addressing female fertility. 2 July 2016
It is no secret that companies which are able to successfully develop biosimilar versions of big-selling biologics in the next five to 10 years will be onto a good thing. 1 July 2016
US pharma giant Pfizer today announced that it will invest around $350 million in the development of a state-of-the-art Global Biotechnology Center at a ground-breaking ceremony in the Hangzhou Economic Development Area (HEDA) in China. 28 June 2016
Indian generics drugmaker Hetero said today it has launched a biosimilar of bevacizumab, the active ingredient of Swiss pharma giant Roche’s blockbuster cancer drug Avastin, in India for the treatment of metastatic colorectal cancer (mCRC). 27 June 2016
The biosimilars pipeline of the South Korean company Samsung Bioepis would be highly impressive if it belonged to a long-established, world-leading pharma giant. 22 June 2016
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
Sign up to receive email updates Join industry leaders for a daily roundup of biotech & pharma news
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.