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Pills V13D05

Celltrion–Rani partnership for RaniPill biosimilars

Home/Pharma News | Posted 14/07/2023

Celltrion and Rani Therapeutics (Rani) have entered a partnership under which Celltrion will supply ustekinumab and adalimumab biosimilars for RaniPill products under an exclusive license and supply agreement.

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Cuba strengthens biotech industry through Eurasian partnerships

Home/Pharma News | Posted 14/07/2023

Cuba is consolidating its position in the field of biotechnology thanks to cooperation with several Eurasian nations, in particular Russia and Belarus.

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Biosimilars manufacturing facilities approved by EU and US

Home/Pharma News | Posted 06/06/2023

Two biological drugs manufacturing facilities for biosimilar epoetin alfa and biosimilar bevacizumab were approved in the US and Europe in May and April 2023, respectively.

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Cuba and China strengthen scientific cooperation for the development of medical treatments

Home/Pharma News | Posted 30/05/2023

In recent years, Cuba and China have established agreements to develop innovative medical treatments, notably Center for Genetic Engineering and Biotechnology (Centro de Ingeniería Genética y Biotecnología, CIGB) and Center for Molecular Immunology (Centro de Inmunología Molecular, CIM), and have shared their experiences in the field of medical research.

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HK inno.N–mAbxience partnership in Korea and Coherus advances in the US

Home/Pharma News | Posted 17/02/2023

In early 2023, it was announced that South Korea’s HK inno.N signed an exclusive license agreement with Spain's mAbxience to bring a denosumab biosimilar to market in South Korea. In addition, in the US, Coherus BioSciences is to acquire exclusive commercial rights to Formycon’s under-development Eylea (aflibercept) biosimilar.

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Global marketing and commercialization advances for Alvotech and partners

Home/Pharma News | Posted 27/01/2023

In late 2022 and early 2023, Alvotech announced several strategic partnership advances to further their global reach as a biotech company specializing in the development and manufacture of biosimilar medicines.

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New partnerships: Biocon-Yoshindo and Syna-Intas

Home/Pharma News | Posted 25/11/2022

Biocon Biologics announced on 17 October 2022 that it has entered into a strategic out-licensing agreement with Japanese pharmaceuticals company Yoshindo for commercializing two of its pipeline biosimilar assets in Japan. Following this, on 2 November 2022, Syna Therapeutics signed an exclusive license agreement with Intas to commercialize a haematology biosimilar.

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Similis-Blau biosimilars development partnership announced

Home/Pharma News | Posted 04/11/2022

On 25 October 2022, JSR Life Sciences (and LLC (JSR)) have announced that their recently launched biosimilars development branch, Similis Bio, has signed a development and license agreement with Brazilian firm, Blau Farmacêutica. 

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GaBI news digest for 14 October 2022

Home/Pharma News | Posted 14/10/2022

Selected news for the week of 14 October 2022 for GaBI readers.

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FDA inspections in Iceland and Singapore for Alvotech and Strides

Home/Pharma News | Posted 14/10/2022

On 5 September 2022, Alvotech announced that it had received communication from the US Food and Drug Administration (FDA) that detailed the assessment of their Icelandic manufacturing facility and Alvotech’s subsequent written responses to FDA. This followed Strides announced the successful FDA inspection of their Singapore facility in early August 2022.

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Novartis is set to spin-off Sandoz

Home/Pharma News | Posted 16/09/2022

Big pharma company Novartis announced on 25 August 2022 that it will spin off its generics and biosimilars arm, Sandoz.

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New partnerships: Prestige-Intas and Samsung Bioepis-Samil

Home/Pharma News | Posted 02/09/2022

Prestige Biopharma (Prestige) and Intas Pharmaceuticals have entered a partnership to supply and commercialize Prestige Biopharma’s bevacizumab biosimilar in a number of countries globally. In addition, Samsung Bioepis has partnered with Samil to market their Lucentis (ranibizumab) biosimilar for ophthalmic diseases in South Korea.

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Organon–Henlius partnership: biosimilars for women’s health

Home/Pharma News | Posted 24/06/2022

Organon, a global specialist in women’s health and expert in biosimilar commercialization, announced in mid-June 2022 that it had entered into an agreement with Shanghai Henlius Biotech, Inc. As part of this, Organon will license commercialization rights for biosimilar candidates referencing Perjeta (pertuzumab), and Prolia/Xgeva (denosumab) and will have global rights except for in China and its territories.

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EMA authorizations: CRO generics suspended and Herceptin biosimilar refused

Home/Pharma News | Posted 17/06/2022

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has suspended the marketing authorizations of several generics medicines tested by Synchron Research Services on 20 May 2022. The committee also refused the marketing authorization for BioPharma’s Herceptin biosimilar, Tuznue, on 19 May 2022.

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Lupin–Yabao partnership to bring paediatric medicines to China

Home/Pharma News | Posted 20/05/2022

In April 2022, global pharmaceutical company, Lupin announced that it has entered a strategic partnership with China’s Yabao Pharmaceutical Company. Together, the companies will work to meet the growing demand for quality drugs with paediatric formulations in Chinese markets.

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Biosimilar Solutions to start trials of biosimilar filgrastim and GMP manufacturing

Home/Pharma News | Posted 16/05/2022

In late-March and mid-April 2022, Biosimilar Solutions Inc (Biosimilar Solutions) announced the start of its registrational clinical trials for BSC1020 and BSC0826 biosimilar filgrastim and on 14 March 2022, OcyonBio LLC (OcyonBio) announced a manufacturing and operations agreement to develop biosimilar drug product facilities for Biosimilar Solutions in Puerto Rico.

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Aurobindo acquires Veritaz and Formycon–ATHOS partnership

Home/Pharma News | Posted 22/04/2022

In April 2022, Indian drugmaker, Aurobindo Pharma, acquired formulations business Veritaz. In addition, biosimilars specialist, Formycon, signed a partnership deal with ATHOS to merge development activities surrounding two biosimilars.

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Fresenius Kabi acquire mAbxience and Ivenix

Home/Pharma News | Posted 15/04/2022

Fresenius Kabi is acquiring a majority stake in biosimilars company mAbxience, and is acquiring infusion pump maker, Ivenix outright. The deals are set to be completed by mid-2022.

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Cipla–mAbxience partnership in South Africa

Home/Pharma News | Posted 08/04/2022

Cipla Medpro announced a partnership agreement with the global biotechnology company mAbxience in March 2022. This aims to provide essential oncology and respiratory-related biosimilars in South Africa.

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Biocon to acquire biosimilars business from Viatris

Home/Pharma News | Posted 01/04/2022

India-based biologicals specialist Biocon Biologics (Biocon) announced on 28 February 2022 that it has entered into a definitive agreement with its partner Viatris (formerly Mylan) to acquire the latter’s biosimilar business.

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Private equity firms poised to bid for Sandoz takeover

Home/Pharma News | Posted 25/03/2022

Following the late 2021 reports that Novartis is considering a possible sale or spinoff of its generics (and biosimilars) unit, Sandoz [1, 2], two private equity firms are now reportedly discussing a joint bid for the unit.

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AbbVie and Alvotech settle Humira (adalimumab) disputes

Home/Pharma News | Posted 18/03/2022

US firm AbbVie and Iceland-based Alvotech have announced a resolution to the patent and trade secret disputes regarding Humira (adalimumab), for which Alvotech is developing a biosimilar.

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Biogen and Xbrane form agreement for arthritis biosimilar

Home/Pharma News | Posted 04/03/2022

Biogen and Xbrane Biopharma (Xbrane) have announced a commercialization and licensing agreement for a biosimilar of certolizumab pegol (Cimzia), which can be used to treat rheumatoid arthritis and other inflammatory conditions.

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Axantia to market Lupin’s pegfilgrastim in the Middle East and North Africa

Home/Pharma News | Posted 25/02/2022

On 1 February 2022, Indian multinational pharmaceutical company Lupin Ltd announced that it was entering into a License, Supply and Technology Sharing agreement with Axantia, to market Lupin’s pegfilgrastim biosimilar in certain territories in the Middle East and North Africa.

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Orion-CuraTeQ and Theramax-Enzene Biosciences partnerships

Home/Pharma News | Posted 18/02/2022

In January 2022, Finnish company Orion Corporation and CuraTeQ Biologics, subsidiary of India’s Aurobindo Pharma, announced their European expansion to the Baltic countries. This follows the December 2021 announcement that the UK’s Theramex entered into an agreement with India’s Enzene Biosciences to develop, register and commercialize a biosimilar of Roche’s RoActemra® (tocilizumab).

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Biocon–Viatris merger expected

Home/Pharma News | Posted 11/02/2022

The merger of India’s Biocon Biologics and Viatris’ biosimilar business are reported to be in advanced stages.  

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Samsung to take full control of Samsung Bioepis

Home/Pharma News | Posted 04/02/2022

Korean electronics giant Samsung has made a deal with US biotechnology company Biogen Idec (Biogen) to take full ownership of their joint biosimilars venture, Korea-based Samsung Bioepis.

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Top 10 most read GaBI Online articles in 2021

Home/Pharma News | Posted 28/01/2022

A review of the Top 10 most read articles reveals that biosimilars are still of most interest to readers. Some of the most memorable events for biosimilars in 2021 were recommendations for biosimilar approvals by the European Medicines Agency (EMA) and by China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), as well as summaries of biosimilar approvals in Uruguay and Paraguay. Other subjects of interest included naming for biosimilars in the US, the interchangeability of EU biosimilars, Federal purchases of biologicals for cancer in Brazil. Finally, how patent litigation creates barriers to US biosimilar market growth and how competition from biosimilars drives price reductions for biologicals in France was also of interest to readers.

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Fresh partnerships announced for ranibizumab and trastuzumab biosimilars

Home/Pharma News | Posted 21/01/2022

Prestige BioPharma has partnered with Dr Reddy’s Laboratories (Dr Reddy’s) to commercialize their trastuzumab biosimilar, HD201, while MS Pharma has joined up with Formycon for the commercialization of its ranibizumab biosimilar, FYB201.

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Spinoff updates: Merck’s Organon and Novartis’ Sandoz

Home/Pharma News | Posted 26/11/2021

Merck spinoff Organon has announced third quarter revenue of US$1.6 billion in 2021. This shows slight decline in women’s health medications but growth in biosimilar sales. Following its 2021 third quarter review, Novartis is considering the spinoff of its biosimilar division, Sandoz, as a standalone company.

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Swiss Social Democrat’s for nationalization of Sandoz

Home/Pharma News | Posted 19/11/2021

In November 2021, the Social Democratic party in Switzerland urged the government to buy Novartis AG’s generics and biosimilars unit, Sandoz. 

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Biocon Biologics and Serum Institute Life Sciences partnership

Home/Pharma News | Posted 12/11/2021

On 16 September 2021, a strategic partnership was announced between India-based biologicals specialist Biocon Biologics Limited (BBL), and Indian vaccine manufacturer Serum Institute Life Sciences (SILS), a subsidiary of Serum Institute of India Pvt Ltd.

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Ustekinumab biosimilars: new international biopharma agreements

Home/Pharma News | Posted 12/11/2021

September and October 2021 saw new international agreements between biopharmaceutical companies regarding ustekinumab biosimilars. These were formed between BioFactura and Rani Therapeutics in the US, and China’s Bio-Thera Solutions and Pharmapark in Russia. 

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Agreement to produce similar biotherapeutic product in Turkey

Home/Pharma News | Posted 05/11/2021

On 22 October 2021, an important agreement was signed between Nobel Pharmaceuticals and the IBG-OzBio partnership for the manufacturing of a similar biotherapeutic product in Turkey. This hopes to be a springboard for further collaborations and medicinal product development in the country. 

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Collaborations to commercialize oncology biosimilars

Home/Pharma News | Posted 22/10/2021

New collaborations to commercialize oncology biosimilars have been announced between Sandoz and Bio-Thera Solutions, and between Innovent Biologics and Ascentage Pharma.

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Licensing agreements signed for ustekinumab biosimilars

Home/Pharma News | Posted 17/09/2021

Bio-Thera Solutions have signed an exclusive commercialization and licensing agreement with Hikma Pharmaceuticals for the ustekinumab (Stelara) biosimilar BAT2206, similar to an agreement reached between Meiji Seika Pharma, Dong-A ST and Intas Pharmaceuticals.

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Oncogen–BrightGene partnership

Home/Pharma News | Posted 10/09/2021

In June 2021, Malaysian oncology generics company, Oncogen, and China’s BrightGene Bio-Medical Technology announced that they are partnering to develop, manufacture, market and distribute generic drug products for the US market. 

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Menagen–CKD Middle Eastern partnership

Home/Pharma News | Posted 03/09/2021

Omani company, Menagen Pharmaceutical Industries and Korean company, Chong Kun Dang Pharmaceutical Corp (CKD), have formed a strategic partnership to provide biosimilars to countries in the Middle East.

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Teva signs deal with Bioeq for ranibizumab biosimilar FYB201

Home/Pharma News | Posted 30/07/2021

Israeli generics giant Teva Pharmaceutical Industries (Teva) and Swiss biotechnology company Bioeq AG announced on 28 June 2021 that they had entered into a strategic partnership for the exclusive commercialization of Bioeq’s candidate ranibizumab biosimilar (FYB201) in Europe, Canada, Israel and New Zealand.

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Organon launches as new global women’s health company and appoints leaders in Latin America

Home/Pharma News | Posted 23/07/2021

Organon celebrated its launch as a global women’s health company on 3 June 2021 with employees and women from around the world, as the Organon executive leadership team rings the opening bell at the New York Stock Exchange.