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.
US biotech giant Amgen yesterday announced the submission of a Biologics License Application (BLA) with the US Food and Drug Administration for ABP 501, a biosimilar candidate to Humira. 26 November 2015
The type 1 diabetes mellitus (T1DM) market across the eight major countries of the USA, Canada, France, Germany, Italy, Spain, the UK and Japan will expand from $4.2 billion in 2014 to $7.1 billion by 2021, at a robust compound annual growth rate (CAGR) of 7.9%, new research indicates. 25 November 2015
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 10 medicines for marketing authorization at its November 2015 meeting. 22 November 2015
The European Generic and Biosimilar Medicines Association (EGA) and the Spanish Generic Medicines Association (AESEG) are joining forces to increase Spanish patients’ access to generic and biosimilar medicines, highlighting the importance of introducing measures that will increase access to high quality medicines and remove market barriers. 19 November 2015
The US Food and Drug Administration has accepted the regulatory submission by Sandoz, the generics division of Novartis, for its biosimilar pegfilgrastim. 18 November 2015
Four policy priorities that will safeguard affordable access to medicines in Australia while ensuring the generic and biosimilar medicines industry remains viable have been agreed to by the federal government. 10 November 2015
Amgen yesterday presented detailed findings from a head-to-head Phase III study comparing the safety, efficacy and immunogenicity of biosimilar candidate ABP 501 with adalimumab. 10 November 2015
The European Biosimilar medicines Group (EBG, the sector group of the European Generic and Biosimilar Medicines Association [EGA]) has been keenly involved in the DIA conference over the last two days to promote greater access to biological medicines for patients. 5 November 2015
The Biosimilars Council, a division of the US Generic Pharmaceutical Association (GPhA), says it is disappointed today by the Centers for Medicare & Medicaid Services’ (CMS) decision to group all biosimilars together under one payment calculation and billing code in Medicare Part B, while using a different code for the reference product. 3 November 2015
The claim on Rituxan/MabThera (rituximab) intellectual property (IP) by Genentech, the biotech subsidiary of Swiss pharma giant Roche, has been dissolved by Russia’s Biocad. 3 November 2015
The breast cancer market will have grown to almost $20 billion across the major markets (USA, France, Germany, Italy, Spain, UK and Japan), corresponding to an impressive annual growth rate of 5%. 2 November 2015
Germany’s contract development and manufacturing firm ProBioGen AG and Indonesian state-owned vaccines maker Bio Farma have signed an agreement for the development of a biosimilar trastuzumab. 30 October 2015
The staff of the US Federal Trade Commission has submitted a comment to the Food and Drug Administration in response to the FDA’s request for comment on its draft guidance addressing non-proprietary names for biological products. 29 October 2015
German family-owned drugmaker Boehringer Ingelheim has announced positive Phase I results of a study to prove pharmacokinetic bioequivalence of its biosimilar for Abbvie's Humira (adalimumab). 29 October 2015
Drugmaker Dr Reddy’s Laboratories on Thursday reported a 26% rise in second quarter profit, ahead of analyst estimates, boosted by strong sales in North America, Europe and India. 29 October 2015
New clinical data indicate no differences in efficacy, adverse events and immunogenicity when patients with inflammatory bowel disease (IBD) are switched to the biosimilar infliximab Remsima from originator infliximab (Remicade, the reference medicinal product from Johnson & Johnson. 28 October 2015
EMD Millipore has entered into a strategic alliance with Turgut Ilac, a leading biosimilars company based in Turkey and will provide their Provantage End-to-End services for development and manufacturing of biologics. 22 October 2015
Biotechnology company mAbxience has officially opened the first single-use technology plant in Spain focused on the development of these medicines. 19 October 2015
The USA’s Biosimilars Forum has expressed support for Senators Pat Roberts (Republican, Kansas) and Tom Carper (Democrat, Delaware) as well as 18 additional Senators for their leadership in sending a letter to Andrew Slavitt, Acting Administrator for the Centers for Medicare & Medicaid Services (CMS) regarding the provisions relating to biosimilar reimbursement in the CMS's 2016 Medicare Physician Fee Schedule proposed rule. 13 October 2015
The US Generic Pharmaceutical Association (GPhA) and its Biosimilars Council remain hopeful that discussions in Atlanta translate to Trans-Pacific Partnership (TPP) language that promotes access to treatments for patients all over the world. 3 October 2015
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.