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.
Russia’s largest pharma company Pharmstandard and Millhouse, an investment company owned by Russian billionaire Roman Ambromovich (in some quarters best known as the owner of the UK premier League football club Chelsea), have announced plans to acquire significant stakes (individually) in Biocad Holding, the main shareholder in biotechnological company CJSC Biocad, Russia’s largest biotech firm, which has recently been in the news for getting regulatory approval of some blockbuster biological biosimilars (The Pharma Letters passim). 23 May 2014
Russian Prime Minister Dmitri Medvedev on Monday visited the commercial manufacturing facility for monoclonal antibody (MAb)-based therapeutic proteins of Russia’s lading biotech company CJSC Biocad. 20 May 2014
A biosimilar of Swiss drug major Roche’s MabThera (rituximab), to be marketed under the trade name AcellBia, is the first monoclonal antibody (MAb) biosimilar to receive a positive opinion from the Russian regulatory body, says Russia’s leading biotech company Biocad, which has developed the product. 15 May 2014
US generics major Actavis (NYSE: ACT) has announced the proposed senior management team that will lead the company pending the successful close of the acquisition of Forest Laboratories, anticipated mid-year. 14 May 2014
The UK trade body the Association of British Pharmaceutical Industries (ABPI) has launched the third edition of its position paper on biosimilar medicines, which makes seven recommendations covering areas where action is needed. 14 May 2014
German pharma and chemical major Merck KGaA has said it is planning to invest in innovations to ensure operational growth in 2014 and the years to come. 12 May 2014
Swiss drug major Roche may lose an important $240 million contract in Russia for the supply of its anti-cancer drug MabThera (rituximab), as Russia’s leading biotech company Biocad, based in St Petersburg, has recently registered its biosimilar of MabThera. 7 May 2014
USA-based Hospira has announced positive results from a post-authorization observational safety study of biosimilar epoetin product Retacrit/Silapo (epoetin zeta) in patients with renal anemia. 28 April 2014
Indian drugmaker Lupin has entered into a strategic joint venture agreement with Japanese pharma company, Yoshindo to create a new entity, YL Biologics (YLB). YLB will be jointly managed by both partners and will be responsible for conducting clinical development of certain biosimilars including regulatory filings and obtaining marketing authorizations in Japan. 23 April 2014
Boston-based privately-held Epirus Biopharmaceuticals, focused on the global development and commercialization of biosimilar monoclonal antibodies, plans to acquire Zalicus in an all-stock merger transaction. 16 April 2014
Brazilian biotech company Bionovis and Germany’s Merck KGaA have signed an agreement for the development and production of biological medicines in Brazil, according to Brazil Pharma News. 14 April 2014
The president of the European Generic Medicines Association (EGA), Nick Haggar, attended the Stati Generali della Salute Conference in Rome, Italy, this week at the invitation of Italian Minister of Health, Beatrice Lorenzin. The conference was attended by European and Italian policy makers and stakeholders discussing the main challenges affecting the health sector in Italy. 9 April 2014
Uptake of biosimilars in Europe has increased as a result of member states’ policies, according to Ken Walsh, Global Pricing & Market Access, of Swiss drug major Novartis' generics unit Sandoz, who spoke at the European Generic medicines Association’s (EGA) 12th annual conference on biosimilar medicines in London last week. 7 April 2014
The spotlight was on the European uptake of biosimilars at the European Generic medicines Association’s (EGA) 12th annual conference on biosimilar medicines in London last week. 7 April 2014
Clear and unbiased information on biosimilars is needed to increase uptake of the medicines across Europe, according to key industry leaders at the European Generic medicines Association’s (EGA) 12th annual conference on biosimilar medicines in London this week. 4 April 2014
South Korea's pharmaceuticals market was valued at $20 billion in 2012, growing from $14.5 billion in 2006 at a compound annual growth rate (CAGR) of 5.5%, according to a new report from researchandmarkets. The market is expected to increase at a CAGR of 7.2% over the 2012-2018 period. 2 April 2014
The Brazilian drugmaker Cristalia has just taken another step towards its goal of producing biosimilar drugs domestically, writes Juliane Carvalho on Brazil Pharma News: www.brazilpharmanews.com 24 March 2014
This week, the Alliance for Safe Biologic Medicines (ASBM) disclosed the results of a survey of 470 European physicians, that took place in the third quarter of 2013, across five EU countries (France, Germany, Italy, Spain, and the UK), regarding their prescribing habits and knowledge of biosimilar medicines. 19 March 2014
The European Union must remove barriers to competition and free trade by introducing common sense reforms to European pharmaceutical intellectual property rules, according to a statement following the European Generic medicines Association 10th Legal Affairs Forum. 19 March 2014
In what must be seen as a significant change in focus, India is now seeing a surge of innovative research in the pharmaceutical and biosimilars sectors, moving away from its traditional role in generics and active pharmaceutical ingredients, reports The Pharma Letter’s India correspondent. 3 March 2014
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.