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Commission (FTC) said yesterday that it has submitted a comment supporting the Food and Drug Administration’s (FDA) draft guidance regarding interchangeable biosimilar drugs. 23 August 2024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
Biosimilar drugs could drive down prices for expensive medicines used to treat illnesses such as cancer and rheumatoid arthritis, with savings estimated to be $38.4 billion or 5.9% of projected total US spending on biologics from 2021 to 2025, according to a new RAND Corporation study. 11 January 2022
Effective January 3, German drugmaker STADA Arzneimittel is strengthening its biosimilars capabilities with the appointment of Erin Federman as global commercial head, Biosimilars and vice president. 5 January 2022
USA-based Viatris announced that it is pleased with decisions issued that affirm the US Patent and Trademark Appeal Board's prior rulings that found the challenged claims of Sanofi's Lantus (insulin glargine) SoloSTAR device patents, US Patent Nos 9,603,044, 8,992,486, 9,526,844, 9,604,008, and 8,679,069, unpatentable. 30 December 2021
Women’s health specialist Theramex has entered into an agreement with Enzene Biosciences to develop, register and commercialise a biosimilar of Roche’s RoActemra (tocilizumab). 24 December 2021
With the recent launch of the Avastin (bevacizumab) biosimilar in China, Henlius, the biotech arm of Fosun Pharma, now has four biosimilars under its belt. However, the Shanghai-based firm is eager to shake off the image of a biosimilars supplier. 22 December 2021
The Food and Drug Administration yesterday approved the second biosimilar insulin product, Eli Lilly’s Rezvoglar (insulin glargine-aglr). 21 December 2021
Over the next decade, many more biological medicines are set to lose market exclusivity, representing an opportunity to increase competition and offer invaluable resources for healthcare systems to improve patient access and healthcare budget sustainability while significantly reducing equity gaps across Europe. 15 December 2021
Hyphens Pharma International, Singapore’s leading specialty pharmaceutical and consumer healthcare group, says that its subsidiary, Hyphens Pharma Pte has signed an exclusive license and supply agreement with DKSH’s subsidiary, Favorex Pte to commercialize the ustekinumab biosimilar produced by Alvotech, in Singapore, Malaysia, and the Philippines. 14 December 2021
Hungary's largest drugmaker Gedeon Richter has reached a deal with London-listed drugmaker Hikma Pharmaceuticals, out-licensing biosimilar denosumab for commercialization in the USA. 9 December 2021
Access to off-patent medicines is essential to increase competition, offer accessible and affordable treatments and for the budgetary sustainability of healthcare systems in Europe, as highlighted by a European Parliament report adopted this week, said Medicines for Europe, the trade group representing generic and biosimilars drugmakers. 29 November 2021
Japanese mid-size drugmaker Mochida Pharmaceutical and Ayumi Pharmaceutical announced that Adalimumab BS MA (adalimumab biosimilar, code: LBAL) has now been launched in Japan as the NHI (National Health Insurance) drug price has been listed today. 25 November 2021
Typically, in the USA, the list prices of biosimilars at launch have been 15% to 35% lower than that of the corresponding reference products, and the biosimilar market is estimated to lead to savings of $133 billion over the next five years.1,2 22 November 2021
Biologic medicines are among the most innovative drugs to treat many life-threatening conditions, including cancer and autoimmune diseases. 17 November 2021
Medicines for Europe, a trade group representing the generic and biosimilars sector in the region, has applauded efforts by the European Commission to improve the current intellectual property regime. 12 November 2021
Eager to create an ecosystem for innovation, a draft policy document prepared by India's Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers has proposed to cut down the time taken for regulatory approvals for innovative products by at least 50% within the next two years. The policy aims to catalyze R&D in the pharma and medtech sector, and to propel India to become a leader in drug discovery through incubating an entrepreneurial environment, reports The Pharma Letter’s India correspondent. 10 November 2021
Chinese biotech Bio Thera Solutions has filed a new drug application (NDA) with China’s National Medical Products Administration (NMPA) to gain approval of what would be the country's first biosimilar of Actemra (tocilizumab). 10 November 2021
Copycat biologics are helping to expand access to care for cancer patients, according to a report from the Association for Accessible Medicines (AAM), which represents the USA’s generics and biosimilars companies. 3 November 2021
Semglee (insulin glargine-yfgn), an insulin glargine biosimilar developed by Indian company Biocon, has been listed as a preferred brand by one of the USA’s largest pharmacy benefit managers, Express Scripts. 21 October 2021
A slew of regulatory reforms is in the offing for the biotech industry in India, with the government seeking to accelerate biologics and biosimilar development in the country. Apart from an amendment to Guidelines on Similar Biologics, the industry is to get the benefit of certain measures that will facilitate commercial stockpiling of biosimilar products before issuance of marketing authorization in order to propel their launch in the market in line with the US Food and Drug Administration, reports The Pharma Letter’s India correspondent. 19 October 2021
China’s Bio-Thera Solutions has reached a licensing and supply agreements with Pharmapark for BAT2206, its ustekinumab biosimilar, under which Pharmapark will have exclusive rights to distribute and market the drug with a status of a local product in Russia and other Commonwealth of Independent States (CIS) countries. 18 October 2021
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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.