Pharma News

Fresenius Kabi and Formycon reach agreement with J&J, Alvotech and Teva expand partnership

Home/Pharma News | Posted 08/09/2023

In August 2023, Fresenius Kabi and Formycon announced that they have entered into a settlement agreement with Johnson & Johnson (J&J) concerning FYB202, a proposed ustekinumab biosimilar in the US. This followed the late July 2023 news that Alvotech and Teva Pharmaceuticals (Teva) have agreed to expand their existing strategic partnership agreement.

Cuba and China strengthen ties in biotechnology

Home/Pharma News | Posted 01/09/2023

The biotechnological cooperation between Cuba and China has been a longstanding relationship in the scientific and technological realms. For the benefit of both countries, Havana and Beijing have undertaken various collaborations in the field of biotechnology, driven by their bilateral relations and shared interest in the development of the healthcare and pharmaceutical industry.

New BioFactura-CuraTeQ partnership for ustekinumab biosimilar

Home/Pharma News | Posted 25/08/2023

CuraTeQ Biologics Private Limited, a subsidiary of India’s Aurobindo Pharma Limited, has entered into an exclusive license agreement to commercialize BFI-751, BioFactura’s proposed biosimilar to Stelara (ustekinumab).

Four drugmakers sue the US government over the Inflation Reduction Act

Home/Pharma News | Posted 18/08/2023

In July 2023, Johnson & Johnson became the fourth large drugmaker to sue the US government over drug price negotiations in the Inflation Reduction Act (IRA). They join, Merck, Bristol Myers Squibb and Astellas in claiming that price negotiations by Medicare violate the First and Fifth Amendments of the US Constitution.

J&J lawsuits settled over ustekinumab biosimilars

Home/Pharma News | Posted 24/07/2023

Johnson & Johnson (J&J), the maker of Stelara (ustekinumab), settled two lawsuits, one against Amgen, and the other against Alvotech and Teva Pharmaceuticals. Both lawsuits were over proposed ustekinumab biosimilars for the treatment of autoimmune conditions. These were settled in May and June 2023,respectively.

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.

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.

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.

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.

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.

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.

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.

New funding to strengthen Cuba's biopharmaceutical industry

Home/Pharma News | Posted 18/11/2022

On 22 September 2022, the United Nations Development Programme (UNDP) announced the execution of a loan of Euros 46.7 million (US$45.25 million dollars) to support Cuba's biopharmaceutical industry and improve the country's capacity to respond against diseases such as COVID-19.

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.

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.

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.

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.

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.

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.

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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