Latest Pharma and Biotech News

Zombie contagion: protecting biotech's future from within

4 July 2025 An Expert View from Justin Kozak, life sciences industry lead, Founder Shield.

Refine Search

USA-based Pfenex has granted the China NT Pharma Group non-exclusive development and exclusive commercialization rights to PF708, a teriparatide therapeutic equivalent candidate to Forteo, 21 April 2018

It was no fluke when Celltrion Healthcare became the first drug developer to win approval for a biosimilar monoclonal antibody (mAb) from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) with its copy of Remicade (infliximab). 13 April 2018

During the recent National Health Policy Conference run by America’s Health Insurance Plans, the US Food and Drug Administration’s Commissioner Dr Scott Gottlieb shared his candid remarks on the state of the pharmaceutical market in the USA.1 While drug prices are traditionally not part of the FDA’s responsibilities, the physician and cancer survivor was passionate about highlighting his observations of the American healthcare industry, says Dr Nicola Davies in her monthly exclusive blog for The Pharma Letter. 12 April 2018

Mylan today announced it is partnering with Fujifilm Kyowa Kirin Biologics to commercialize FKB327, a biosimilar to Humira (adalimumab) developed by the Japanese firm. 11 April 2018

Chugai Pharmaceutical] announced today that it has decided to waive its claim in a patent infringement lawsuit against Nippon Kayaku. 11 April 2018

Though the cost of developing niche complex drugs and biosimilars is substantially high, the potential opportunity has got Indian drug majors in a frenzy, reports The Pharma Letter’s India correspondent. 10 April 2018

According to a new report, published by MarketsandMarkets, the market for biosimilar medicines is expected to reach a value of $23.63 billion by 2023, up from $5.95 Billion in 2018, expanding at a compound annual growth rate (CAGR) of 31.7%. 9 April 2018

Following warnings from the US Food and Drug Administration last year, and again in February, related to its manufacturing practices, South Korean drugmaker Celltrion has now been handed a Complete Response Letter from the agency related to two of its proposed biosimilars. 6 April 2018

The arrival of competition for Humira (adalimumab), the world’s best-selling drug, in its most lucrative market, remains comfortably far away for AbbVie after the settlement of a patent dispute. 5 April 2018

Our latest Special Report is a review of key factors impeding progress of US biosimilar adoption written by Helen Ji, an associate at Schiff Hardin LLP, Rekha Hanu, executive director and chief IP counsel at Akorn Pharmaceuticals and Christine Simmon, SVP for policy and strategic alliances at the Association for Accessible Medicines. 4 April 2018

Netherlands-incorporated Mylan and Indian development partner Biocon have been granted European approval for their biosimilar insulin glargine product Semglee. 28 March 2018

Biosimilars are becoming increasingly popular with pharmaceutical companies, however, knowing which markets have been saturated with biosimilars and which are open, remains an important consideration for pharma companies. 23 March 2018

Celltrion Healthcare has granted exclusive distribution rights to its trastuzumab biosimilar, Herzuma, in seven European Union markets including Germany, Italy and the UK. 19 March 2018

New clinical data will support the use of a biosimilar treatment for Crohn’s disease (CD), and lead to a boost in biosimilar market value, a new report suggests. 16 March 2018

The number of first approvals for biosimilars in the USA, Japan, or European Union has increased significantly in the past two years, breaking the stagnation of the three years prior, with 2017 setting a new record for number of first approvals in a single year, according to a new analysis. 13 March 2018

Merck & Co has announced the launch of Ontruzant, the first biosimilar version of Roche’s big-selling cancer drug Herceptin (trastuzumab), for patients in the UK. 7 March 2018

The European Medicines Agency has accepted the regulatory resubmission of a proposed biosimilar to Amgen’s (Nasdaq: AMGN) Neulasta (pegfilgrastim). 6 March 2018

Mylan and Revance Therapeutics today announced a global collaboration and license agreement for the development and commercialization of a proposed biosimilar to Botox (onabotulinumtoxinA). 1 March 2018

Following the approval of a Remicade (infliximab) biosimilar from Russian company Biocad in its home country last month, the company anticipates that this product will enter other markets at the end of 2018 or in early 2019. 20 February 2018

Biosimilars

Biosimilar Herzuma approved in EU

The European Commission (EC) has approved Herzuma (trastuzumab biosimilar) for the treatment of patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification. 14 February 2018

Previous page 30 31 32 333435 36 37 38 39 Next page

All news

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

12 3 4 5 6 7 8 9 10 Next page

Latest Pharma and Biotech News

Today's issue

All news

Company Spotlight