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.
At its July 2014 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued positive opinions for the recommendation of a number of new drugs, including the following: 26 July 2014
The US Food and Drug Administration has accepted the Biologics License Application for filgrastim, which was filed under the new biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA), by Sandoz, the generics business of Swiss pharma major Novartis. 25 July 2014
USA-based Hospira, a leading provider of generic injectable drugs and infusion technologies, announced that its biosimilar epoetin, Retacrit (epoetin zeta), was effective in the management of chemotherapy-induced anemia in patients with solid tumors, lymphoma and myeloma. 24 July 2014
The global biosimilars market could reach $35 billion by 2020, rising from the $1.3 billion it was worth in 2013, according to research published in a report by Allied Market Research. 22 July 2014
The Association of the British Pharmaceutical Industry (ABPI) and the Bioindustry Association (BIA) have teamed up to develop material on biological medicines including biosimilars to improve prescriber and stakeholder understanding and perceptions. 21 July 2014
India’s Strides Arcolab has made a series of strategic investments in Oncobiologics, a privately held New Jersey, USA, biopharmaceutical firm developing a pipeline of biosimilars and next generation biotherapeutics. 16 July 2014
This month, the government of Brazil’s State of Rio de Janeiro, the Brazilian Development Bank (BNDES), the Vital Brazil Institute (IVB), Bionovis and Fiocruz signed an agreement to invest 550 million real ($248.4 million) in the biotechnology company, reports Juliane Carvalho of Brazil Pharma News. 7 July 2014
A total of 32 organizations have signed a letter calling on the US Food and Drug Administration to require biologics and biosimilars to have the same International Nonproprietary Name (INN), a practice currently in use in Europe and other markets. 2 July 2014
Cipla has collaborated with fellow Indian drugmaker Hetero to launch a biosimilar of the drug darbepoetin alfa, US biotech major Amgen's anemia drug Aranesp, under the brand name Actorise. 30 June 2014
The imminent patent expiration of French pharma major Sanofi’s Lantus (insulin glargine) has opened the door for Eli Lilly to increase its share of the diabetes treatment market, and the USA-based company has three big weapons in its pharmaceutical arsenal, says an analyst with research and consulting firm GlobalData. 26 June 2014
Taiwan biopharma company JHL Biotech say it has closed a Series B financing round of $35 million, led by new investors Milestone Capital and a consortium of Taiwan venture capitalists and individuals. 22 June 2014
For the first time, US pharma major Eli Lilly and family-owned German major Boehringer Ingelheim presented data showing that LY2963016, the alliance's investigational new insulin glargine product, has a similar safety and efficacy profile to currently marketed insulin glargine (Lantus). 15 June 2014
Biosimilar medicines will deliver an opportunity for increased access to better healthcare for patients and significant cost savings, provided that policies supporting a sustainable biosimilar medicines market are in place, revealed a report from GfK Market Access. 13 June 2014
USA-based privately-held Epirus Biopharmaceuticals, focused on the development and commercialization of biosimilar monoclonal antibodies, today announced clinical data from a Phase III study of the efficacy and safety of BOW015, a biosimilar infliximab, in patients with active rheumatoid arthritis (RA). 12 June 2014
The increasing prevalence of biosimilars will have a noticeably negative impact on the biologics market beyond 2019, despite an initial projected compound annual growth rate (CAGR) of 8.3%, taking the overall biologics market value from $162 billion in 2013 to more than $262 billion by 2019. 11 June 2014
Certain targeted therapies enjoy extensive but incomplete coverage in Brazil and Mexico through complex mechanisms, according to research by Decision Resources Group. 10 June 2014
The increased number of health related proposed country specific recommendations (CSR) to European Union member states by the European Commission for 2014-2015 offers an opportunity to promote healthcare reforms that support improved access to medicines, says the European Generic Medicines Association (EGA). 5 June 2014
The European Generic Medicines Association (EGA) has welcomed the 67th World Health Assembly’s Resolution on Access to biotherapeutic products including similar biotherapeutic products and ensuring their quality, safety and efficacy and the Resolution on Regulatory system strengthening for medical products. 4 June 2014
The European Generic Medicines Association (EGA) participated in several meetings with Japanese government officials and regulators, the Japanese Generic Medicines Association (JGA), the Nippon Keidanren (Japanese Industry Association) and the European Union Delegation to Japan to promote regulatory cooperation on generic and biosimilar medicines as part of the EU-Japan free trade negotiations. 29 May 2014
In a bid to encourage new and innovative ideas for research and commercialization, the Indian government's Department of Biotechnology has invited proposals from Indian biotech companies for funding of R&D, reports The Pharma Letter's India correspondent. 27 May 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.