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Biotechnology
19 May 2025 Adopting a platform approach to designing new therapies will speed the delivery of innovative genomic treatments to patients—but only if developers, regulators, and manufacturers work together to evolve the current drug development paradigm, writes Vanessa Almendro, vice president of science and technology and head of innovation at Danaher Corporation, in an Expert View piece.
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Biosimilars
Formycon and its commercialization partner Fresenius Kabi have announced that the US Food and Drug Administration (FDA) has designated FYB202/Otulfi (ustekinumab-aauz) as interchangeable with Johnson & Johnson’s (NYSE: JNJ) reference biologic Stelara (ustekinumab). 19 May 2025
Biosimilars
The US Food and Drug Administration’s (FDA biosimilar approvals reached a record 19 in 2024, with projections indicating that 2025 could surpass this milestone trend. 16 May 2025
Biosimilars
Teva Pharmaceutical Industries’ US subsidiary and Iceland-based Alvotech (Nasdaq: ALVO) today announced that the US Food and Drug Administration (FDA) has approved Selarsdi (ustekinumab-aekn) injection as interchangeable with the reference biologic Stelara (ustekinumab). 5 May 2025
Biosimilars
Swiss generics and biosimilars major Sandoz has signed a global collaboration with Shanghai Henlius Biotech to commercialize a biosimilar of leading oncology therapy, ipilimumab, the active ingredient of Bristol Myers Squibb’s blockbuster drug Yervoy. 30 April 2025
Biosimilars
South Korea’s Samsung Bioepis today released its Second Quarter 2025 Biosimilar Market Report, which provides the second quarter 2025 Average Sales Price (ASP) and Wholesale Acquisition Cost (WAC) of the commercially available biosimilars in the USA, as well as the price and market share trends since each biosimilar’s launch. 24 April 2025
Biosimilars
Physician attitudes toward patient choice between the use of biologics and biosimilars vary widely across global markets, revealing deep-rooted cultural and systemic differences. 22 April 2025
Biosimilars
Indian drugmaker Biocon subsidiary Biocon Biologics has announced a settlement and license agreement with the USA’s Regeneron that clears the way to commercialize Yesafili (aflibercept-jbvf), an interchangeable biosimilar aflibercept, in the USA. 17 April 2025
Biosimilars
China’s Chime Biologics has formed a strategic partnership with European biosimilars specialist Polpharma Biologics to support the end-to-end development and manufacture of a biosimilar product targeting the global market. 16 April 2025
Biosimilars
Innovent Biologics has recently received approval for Sycume (teprotumumab biosimilar) to treat thyroid eye disease (TED) in China, making it the country’s first insulin-like growth factor 1 receptor (IGF-1R) monoclonal antibody cleared for TED by the National Medical Products Administration (NMPA). 16 April 2025
Biosimilars
The US Food and Drug Administration (FDA) has designated Yuflyma (adalimumab-aaty) as an interchangeable biosimilar to AbbVie’s mega blockbuster drug Humira (adalimumab), to treat eight conditions, including Crohn's disease and ulcerative colitis. 15 April 2025
Biosimilars
Shares of California-based Coherus BioSciences (Nasdaq: CHRS) rose more than 5% to $0.88 in pre-market activity today as it completed a transformative transaction. 14 April 2025
Biosimilars
Swiss generic and biosimilar medicines firm Sandoz today announced it has filed an antitrust lawsuit in the USA against Amgen for extending and entrenching the dominant market position of its blockbuster medicine, Enbrel (etanercept), first approved by the US Food and Drug Administration (FDA) in 1998. 14 April 2025
Biosimilars
South Korea’s Samsung Bioepis presented data, including the budget impact analysis on ustekinumab biosimilars’ cost savings in Germany, the UK and Sweden at the 8th International Meeting on Intestinal Diseases in conjunction with the Annual Congress of the Korean Association for the Study of Intestinal Diseases (IMKASID 2025) held in Seoul, Korea. 10 April 2025
Biosimilars
Israel-based Teva Pharmaceuticals industries today revealed two important updates reflecting its commitment to expanding access to both biosimilars and innovative medicines. 7 April 2025
Biosimilars
An Expert View from Dr Elena Wolff-Holz, global head of clinical development at Biocon Biologics, the biosimilar subsidiary of Biocon. 7 April 2025
Biosimilars
The European Medicines Agency (EMA) announced it is exploring improvements to the development and evaluation of biosimilar medicines, while upholding strict European Union (EU) safety standards. 2 April 2025
Biosimilars
China's Bio-Thera Solutions has entered into an exclusive commercialization agreement with India's Dr Reddy's Laboratories for two proposed biosimilars referencing Stelara (ustekinumab) and Simponi (golimumab). 1 April 2025
Biosimilars
South Korea’s Celltrion has announced the US launch of Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab), following approval by the US Food and Drug Administration (FDA) in December 2024. 13 March 2025
Biosimilars
US pharma major Bristol Myers Squibb has announced positive data from the pivotal Phase III POETYK PsA-2 trial evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). 10 March 2025
Biosimilars
On Friday, the US Food and Drug Administration (FDA) approved as the first interchangeable biosimilar to Swiss pharma giant Roche's
anti-IgE monoclonal antibody Xolair (omalizumab). 8 March 2025
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Biosimilars
Hailing the benefits of 15 years of biosimilar prescribing in Europe, The Biosimilar Medicines Group has called on the European Medicines Agency to take stronger action to widen access to this type of medicine. 25 January 2022
Biosimilars
The ongoing review of the European pharmaceutical legislation framework is a major opportunity to update the regulatory system in the European Union, says Medicines for Europe, which represents the generics and biosimilars drugmakers. 24 January 2022
Biosimilars
Biosimilars focussed Icelandic company Alvotech Holdings and Oaktree Acquisition Corp. II (Oaktree II), a special purpose acquisition company sponsored by an affiliate of Oaktree Capital Management, today announced $21 million in additional commitments for a private placement (PIPE) of Oaktree II common stock in connection with their proposed business combination. 19 January 2022
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
The Food and Drug Administration yesterday approved the second biosimilar insulin product, Eli Lilly’s Rezvoglar (insulin glargine-aglr). 21 December 2021
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
Biologic medicines are among the most innovative drugs to treat many life-threatening conditions, including cancer and autoimmune diseases. 17 November 2021
Biosimilars
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
Biosimilars
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
Biosimilars
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
Biosimilars
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
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