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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
Poland-based drugmaker Polpharma Biologics today announced that the European Medicines Agency (EMA) has accepted the first-ever Marketing Authorization Application (MAA) for biosimilar natalizumab, a proposed biosimilar to branded multiple sclerosis treatment Tysabri. 15 July 2022
Biosimilars
A proposed biosimilar to Soliris (eculizumab) has shown clinical equivalence in efficacy and safety in people with paroxysmal nocturnal hemoglobinuria (PNH). 12 July 2022
Biosimilars
Market expansion services provider DKSH has partnered with life cycle management company Pharmanovia, to bring high-quality pharmaceutical products to patients across the Asia Pacific. 11 July 2022
Biosimilars
The US Association for Accessible Medicines’ (AAM) Biosimilars Council has released an update on major developments in the biosimilars sector by executive director Craig Burten. 6 July 2022
Biosimilars
Health systems face tremendous challenges across Europe. The management of COVID-19, war in Ukraine and high inflation rates are challenging supply chains for the most essential medicines 1 July 2022
Biosimilars
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of its bevacizumab biosimilar referencing Avastin, Vegzelma (CT-P16), from South Korea-headquartered Celltrion Healthcare. 25 June 2022
Biosimilars
Not content with its journey so far in becoming one of the leading contract development and manufacturing organizations (CDMOs) and the achievements of its Samsung Bioepis venture in the biosimilars field, Samsung Biologics appears to have ambitions in another burgeoning space. 21 June 2022
Biosimilars
Stelis Biopharma, a contract development and manufacturing organization (CDMO) and the biologics arm of India's Strides Pharma Science, has received the European Union Goods Manufacturing Practices (EU-GMP) compliance certificate from the National Institute of Pharmacy and Nutrition, Hungary, for two of its manufacturing facilities. 21 June 2022
Biosimilars
Iceland-based global pureplay biosimilars developer and manufacturer Alvotech announced that its ordinary shares and warrants will begin trading on the Nasdaq Stock Market on Thursday, June 16, under the new ticker symbols “ALVO” and “ALVOW”, respectively. 16 June 2022
Biosimilars
Recently-launched Organon, a women’s health company with expertise in biosimilar commercialization, made an announcement on Monday. 14 June 2022
Biosimilars
German drugmaker STADA Arzneimittel is offering Hukyndra, the high-concentration, citrate-free formulation biosimilar of adalimumab developed by Iceland-based Alvotech Holding, to patients and their caregivers in selected European countries, including France, Germany, Finland, and Sweden. 9 June 2022
Biosimilars
US biotech Biogen and South Korea’s Samsung Bioepis have announced that Byooviz (ranibizumab-nuna), a biosimilar referencing Lucentis (ranibizumab) has been launched in the USA. 3 June 2022
Biosimilars
With media and politicians calling attention to the problem of rising drug prices, it’s important to remember one fact: Generic and biosimilars represent the only segment of health care in the USA that consistently reduces costs, noted the USA’s Association for Accessible Medicines (AAM). 1 June 2022
Biosimilars
Korean biosimilar company Samsung Bioepis is presenting new data on its copy of Humira (adalimumab), which is branded as Imraldi and Hadlima and also referred to as SB5, at the Annual European Congress of Rheumatology (EULAR 2022). 1 June 2022
Biosimilars
Novartis’ generics and biosimilar unit Sandoz has announced the launch of a new global initiative. 31 May 2022
Biosimilars
US drugmaker Amneal has announced that the US Food and Drug Administration (FDA) has approved the company’s Biologics License Application (BLA) for pegfilgrastim-pbbk, a biosimilar referencing Neulasta. 30 May 2022
Biosimilars
Alvotech Holdings, a privately-held Icelandic biosimilars developer, today announced positive results from a confirmatory clinical study for AVT04, the firms proposed biosimilar to Stelara (ustekinumab). 25 May 2022
Biosimilars
India’s Biocon Biologics and US-headquartered Viatris have launched their Abevmy (bBevaczumab) in Canada. 20 May 2022
Biosimilars
The UK Medicines and Healthcare Regulatory Agency (MHRA) decision to grant a licence for Ongavia, a biosimilar to Lucentis (ranibizumab), said the product’s developer, Israeli generics giant Teva Pharmaceutical Industries. 18 May 2022
Biosimilars
Privately-held Icelandic biosimilars developer Alvotech Holdings has announced positive top-line results from a pharmacokinetic (PK) study for AVT04, its proposed biosimilar to Stelara (ustekinumab). 17 May 2022
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