Latest Pharma and Biotech News

Regeneron wins FDA accelerated approval for Lynozyfic in MM

3 July 2025 The US Food and Drug Administration (FDA) has granted accelerated approval for Regeneron Pharmaceuticals’ Lynozyfic (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti CD38 monoclonal antibody.

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7 July 2025

Indian biosimilars developer Biocon Biologics, a subsidiary of Biocon Ltd has announced that the European Commission (EC) has granted marketing authorization in the European Union (EU) for Vevzuo and Evfraxy biosimilars of denosumab, originated by Amgen. 4 July 2025

Swiss biosimilars and generics major Sandoz has announced the start of construction for a new, state-of-the-art biosimilars production center for sterile product manufacturing in Brnik, Slovenia. 2 July 2025

German biosimilars company Formycon has announced that its 2025/2029 corporate bond was significantly oversubscribed due to high demand, leading to an increase in the initially targeted issuance volume from 50 million euros ($59 million) to 70 million euros. 28 June 2025

Indian drugmaker Biocon has announced that Health Canada has granted a Notice of Compliance for Yesafili (aflibercept), a biosimilar to Eylea (aflibercept) injection, in vial and prefilled syringe presentations, 2 mg/0.05 mL. 27 June 2025

Germany’s Formycon announced that Klinge Biopharma, the exclusive owner of the global commercialization rights of FYB203/Ahzantive (aflibercept-mrbb), Formycon’s biosimilar to Bayer’s Eylea, concluded an exclusive license agreement with US biosimilars specialist Valorum Biologics for the commercialization of the product in the USA and Canada. 25 June 2025

South Korea’s biosimilar drug developer Samsung Bioepis today presented the long-term safety data of Epysqli (eculizumab; SB12), a biosimilar to AstraZeneca’s Soliris, in paroxysmal nocturnal hemoglobinuria (PNH) at the European Hematology Association (EHA) Congress 2025 held at Milan, Italy from June 12 to 15. 12 June 2025

Specialty immunotherapy company Tevogen Bio Holdings has announced the execution of a lease agreement to expand its corporate headquarters in Warren, New Jersey, more than doubling its footprint. 10 June 2025

South Korea’s biosimilar drug developer Samsung Bioepis has announced that the company has entered into a license, development and commercialization agreement with Nipro Corporation for multiple biosimilar candidates including SB17, a ustekinumab biosimilar candidate, in Japan. 9 June 2025

Germany’s Formycon has announced that the Brazilian regulatory authority Anvisa has granted marketing authorization for FYB201/Ranivisio, a Lucentis (ranibizumab) biosimilar. 5 June 2025

Swiss generic and biosimilar medicines company Sandoz today announced that Wyost (denosumab) and Jubbonti (denosumab) are available to patients in the USA starting today. 2 June 2025

In a website posting, the International Generic and Biosimilar medicines Association (IGBA) has commended the General Assembly of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) for its adoption of a new topic focused on the harmonization of "Framework for Determining Utility of Comparative Efficacy Studies in Biosimilar Development Programs." 2 June 2025

Indian biosimilars developer Biocon Biologics, a subsidiary of Biocon Ltd , today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for its Yesintek, a biosimilar of ustekinumab, which is marketed under the trade name Stelara by us healthcare giant Johnson & Johnson (NYSE: JNJ) . 27 May 2025

South Korea has launched the Priority Infectious Disease Pandemic Preparedness Rapid R&D Support Program, led by the Korea Disease Control and Prevention Agency (KDCA) in collaboration with SK bioscience. 26 May 2025

The Food and Drug Administration (FDA) has granted an expanded interchangeable designation for Yuflyma (adalimumab-aaty), now including prefilled syringe (40mg) and autoinjectors (40mg and 80mg) presentations. 26 May 2025

South Korean Samsung Group’s biopharmaceutical business is being reorganized into two separate tracks: contract development and manufacturing organization (CDMO) and biosimilars. 22 May 2025

Swiss biosimilars specialist Sandoz has launched what it says is the first autoinjector presentation of a biosimilar to Stelara (ustekinumab) in Europe, bolstering its presence in the region’s rapidly expanding immunology market. 22 May 2025

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

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

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

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Competition from manufacturers of biosimilar drugs, or follow-on versions of complex biotech drugs, is a rising threat for branded pharmaceutical companies, Moody's Investors Service says in a new report. 8 October 2018

The Mundipharma network of independent associated companies today confirmed the appointment of Philippe Bastide, who joins as head of biosimilars, Mint Commercial. 5 October 2018

Kevin Noonan, a partner with McDonnell Boehnen Hulbert & Berghoff, provides commentary on the US Food and Drug Administration's Biosimilars Action Plan in an Expert View piece. 4 October 2018

Momenta Pharmaceuticals says it has completed its strategic review aimed at reducing costs of biosimilar development and focusing its resources on its pipeline of novel drug candidates for immune-mediated diseases. 2 October 2018

Biosimilars

AAM urges action on biosimilars

The US trade group for generics and biosimilars companies has underlined the steps that the US Food and Drug Administration (FDA) can take to further the adoption of affordable copies of expensive biologic medicines. 28 September 2018

The worth of the global biosimilars market will have risen from its $4.36 billion 2016 value by 34% at compound annual growth rate to nearly $20 billion by 2025, a study has predicted. 27 September 2018

Privately-held Alvotech today announced it is entering into a joint venture with China’s Changchun High & New Technology (CCHN) Industries Group, which will enable Iceland-based Alvotech to develop, manufacture and commercialize its biosimilar portfolio in China. 27 September 2018

The European Medicines Agency has approved Pelgraz (pegfilgrastim) and in some countries it could be in the hands of healthcare professionals this week, making it the first biosimilar of Amgen’s (Nasdaq: AMGN) Neulasta to reach patients in Europe. 26 September 2018

The prospect of reducing treatment costs for payors supports a positive future for biosimilars, according to new research released today. 20 September 2018

The USA’s slow uptake of biosimilars compared to Europe and other markets has not helped to bring down the country’s notoriously high drug prices. 17 September 2018

As AbbVie continues to fend of biosimilars competition in the USA for to its mega-blockbuster drug Humira (adalimumab), new data presented at the European Association of Dermatology and Venereology Annual Meeting (EADV 2018) in Paris further support another strong competitor. 12 September 2018

South Korean firm Celltrion Healthcare has called on the UK’s public healthcare provider, the National Health Service (NHS), to consider lowering the threshold for starting biologics in patients with rheumatoid arthritis (RA). 4 September 2018

AryoGen Pharmed has become the first manufacturer of monoclonal antibody (MAb) biologics in the Middle East and North Africa (MENA) region to receive good manufacturing practice (GMP) certification from the European Medicines Agency (EMA). 3 September 2018

A lawyer’s look into the competition provided by biosimilars to biologic therapies has highlighted how this contest differs from generic competitors challenging branded drugs. 29 August 2018

While Indian drugmakers have been hugely successful in the generics arena, if they want to succeed in the potentially more lucrative biosimilars sector, they need to look at acquisitions and partnering, a new study reveals. 14 August 2018

Biosimilars

The FDA's Biosimilar Action Plan

The world’s total expenditure on medicines was $1.135 trillion in 2017 and is projected to reach $1.4 trillion in 2022.1 Understandably, when contemplating such large figures, the reaction from governments, healthcare payers and the public has been to seek more value for every dollar spent, writes Dr Nicola Davies on her regular blog for The Pharma Letter. 13 August 2018

Generic and specialty pharmaceuticals firm Mylan has announced lower than expected second quarter revenues of $2.81 billion, down 5% compared to the prior year period. 8 August 2018

The UK's Department for Health has launched a consultation on its plans to begin applying price controls to biosimilars, proposals that have promptly been ridiculed. 7 August 2018

German generics major Stada Arzneimittel is increasing its presence in the important biosimilar sector by taking a majority stake in an affiliate. 6 August 2018

One small step for biosimilars, one notable leap for Pfizer. 31 July 2018

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