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The US Food and Drug Administration yesterday published a funding opportunity announcement (FOA) for fiscal year 2023 to support research projects that enhance biosimilar and interchangeable biological product development and regulatory science. 17 February 2023

Icelandic firm Alvotech and Germany’s STADA are launching their Humira (adalimumab) biosimilar Hukyndra (adalimumab) in several European countries. 7 December 2022

Industry analyst PharmaVentures have releases a new white paper examining the market landscape and key success factors for biosimilars. 14 November 2022

Adding to the roll out of their biosimilar to AbbVie’s mega blockbuster drug Humira (adalimumab), Icelandic firm Alvotech and German partner STADA Arzneimittel today announced the launch of Hukyndra in Switzerland. 22 September 2022

Biocon subsidiary Biocon Biologics has received a European Union certificate of Good Manufacturing Practice (cGMP) for its Bengaluru, India-based facility. 5 July 2022

India’s Biocon Biologics has launched a new outreach initiative in diabetes, together with Asia’s largest research and professional organization for the therapy area, the Research Society for the Study of Diabetes in India (RSSDI). 15 November 2021

A biosimilar epilepsy treatment, CannEpil+, has been approved for import into the UK. The therapy will be made available for free on compassionate grounds to ten patients for six months, as part of the clinical trial process. 13 September 2021

Samsung Bioepis has announced results from a post-hoc and subgroup analysis of a Phase III study of Byooviz (ranibizumab) in neovascular age-related macular degeneration (nAMD). 9 September 2021

China is about to approve the country's first biosimilar of Amgen's Xgeva (denosumab), which is indicated for the prevention of skeletal-related events in people with bone metastases from solid tumors and in patients with multiple myeloma. 1 September 2021

Biosimilars

BRIEF—New home for Samsung Bioepis

Samsung Bioepis, Korea’s joint venture between Samsung Biologics and Biogen that has become a leader in the global biosimilars market, has opened its new headquarters. 25 January 2021

India’s Biocon Biologics has received a primary equity investment from Abu Dhabi-based ADQ, one of the region’s largest holding companies, worth $75 million. 7 January 2021

The biologics subsidiary of Indian generics company Biocon has received a $150 million capital injection from investment bank Goldman Sachs, subject to customary approvals and conditions. 9 November 2020

Luye Pharma’s biotech subsidiary Boan has licensed LY9004, a biosimilar version of Regeneron and Bayer’s Eylea (aflibercept), to the Chinese ophthalmic drug company Ocumension. 30 October 2020

Taiwan generics and biosimilars supplier Lotus Pharm (a subsidiary of privately-owned US drugmaker Alvogen) signed a licensing deal with the South Korean pharma Chong Kun Dang (CKD) Pharmaceutical. 18 September 2020

Indian drugmaker Lupin and Netherlands-based Mylan have announced the launch of Nepexto, a biosimilar of Amgen’s Enbrel (etanercept), in the German market. 27 August 2020

Mylan and Fujifilm Kyowa Kirin Biologics today announced that the US Food and Drug Administration has approved Hulio (adalimumab-fkjp), a biosimilar to AbbVie's Humira (adalimumab). 9 July 2020

Chinese insulin supplier Gan & Lee Pharmaceutical aims to go public soon in Shanghai Stock Exchange's STAR market, which mimics Nasdaq to attract Chinese innovative companies in the science and technology sector. 9 June 2020

Biosimilars

BRIEF—Fulphila launches in Australia

India’s Biocon and USA-based Mylan have launched Fulphila, a biosimilar to Neulasta (pegfilgrastim), in Australia. 14 April 2020

Japanese drugmaker Daiichi Sankyo has launched a biosimilar product in its home country referencing the Roche cancer drug Avastin (bevacizumab). 19 December 2019

A European trade group has used the publication of an official report to highlight the important role of biosimilar medicines. 28 November 2019

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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

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

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