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Strides and Apotex to merge Australian generics businesses

Home/Pharma News | Posted 22/06/2018

India-based generics manufacturer Strides Shasun (Strides) announced on 9 May 2018 that it had made an agreement with Canada-based Apotex to merge their Australian businesses.

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Sanofi to sell Zentiva generics arm to Advent

Home/Pharma News | Posted 18/05/2018

French drugmaker Sanofi announced on 17 April 2018 that it had entered into exclusive negotiations with Advent International (Advent) under which Advent would acquire Zentiva, Sanofi’s European generics business for Euros 1.9 billion.

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Mylan and Fujifilm Kyowa Kirin Biologics partner on adalimumab biosimilar

Home/Pharma News | Posted 04/05/2018

Fujifilm Kyowa Kirin Biologics announced on 11 April 2018 that it will partner with Mylan to commercialize its adalimumab biosimilar FKB327. Mylan will be granted exclusive commercialization rights for FKB327 in Europe.

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Fujifilm to acquire cell culture media companies

Home/Pharma News | Posted 27/04/2018

Fujifilm is expanding its ability to develop and manufacture biologicals by acquiring a pair of cell culture media businesses owned by Japan-based JXTG Holdings for a combined US$800 million.

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Stada resubmits biosimilar pegfilgrastim but stops adalimumab development

Home/Pharma News | Posted 13/04/2018

German generics giant Stada Arzneimittel (Stada) was informed on 2 March 2018 by Gedeon Richter (Richter) that the European Medicines Agency (EMA) has accepted the regulatory resubmission of its proposed pegfilgrastim biosimilar. However, in another press release the company announced that it was stopping development of its adalimumab biosimilar.

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Korea’s CJ Healthcare shares biosimilar technology with China

Home/Pharma News | Posted 06/04/2018

South Korea’s CJ HealthCare, announced that it has signed a contract with China’s NCPC GeneTech Biotechnology on 31 January 2018 to export CJ-40001, a biosimilar version of darbepoetin alfa which is used for the treatment of renal anaemia. South Korea has well-established guidelines for biosimilars [1], whilst China has finalized the technical guidance for the development and evaluation of copy biologicals in February 2015 [2].

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Biosimilar deals for Hikma and Lupin

Home/Pharma News | Posted 30/03/2018

Collaborations are once again the way forward when it comes to biosimilars. Jordan-based drugmaker Hikma Pharmaceuticals (Hikma) made a licensing deal with South Korean biotechnology company Celltrion in December 2017.  In March 2018 Indian generics maker Lupin Pharmaceuticals (Lupin) made an agreement with the Council of Scientific and Industrial Research-National Chemical Laboratory (CSIR-NCL) and the Department of Science and Technology (DST).

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Mylan and Revance team up for botox biosimilar

Home/Pharma News | Posted 02/03/2018

US-based drugmaker Mylan announced on 28 February 2018 that it had made a deal with Revance Therapeutics to make a biosimilar of Allergan’s cosmetic blockbuster Botox (onabotulinumtoxinA).

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MENA region biologicals maker CinnaGen receives EU GMP certification

Home/Pharma News | Posted 23/02/2018

Iranian biopharmaceutical company, CinnaGen, has been issued a certificate of good manufacturing practice (GMP) compliance by the European Union (EU) at the end of 2017.

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Biocon and Sandoz join forces for global next-generation biosimilars

Home/Pharma News | Posted 15/02/2018

On 18 January 2018, Biocon and Sandoz announced a global partnership to develop, manufacture and commercialize new next-generation biosimilars that will be available worldwide. This collaboration aims to increase global patient access to a range of high quality, affordable immunology and oncology biological medicines.

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Top 10 most read GaBI Online articles in 2017

Home/Pharma News | Posted 12/01/2018

A lot has happened on the subject of biosimilars development in the past year.  An important milestone for biosimilars in 2017 was the issuing of guidance on interchangeability by the US Food and Drug Administration (FDA). While the European Medicines Agency (EMA) approvals of insulin and rituximab biosimilars and the FDA’s approval of adalimumab and bevacizumab biosimilars, altogether three biosimilar cancer monoclonal antibodies have been approved in 2017, will benefit more patients worldwide to targeted biological treatments which were expensive to access in the past. Other subjects of interest for biosimilars were FDA’s update of its Purple Book for biologicals and biosimilars, as well as the studies and evolution in interchangeability, switching and substitution of biosimilars.

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J&J drops lawsuit against Samsung Bioepis over Remicade biosimilar

Home/Pharma News | Posted 05/01/2018

Healthcare giant Johnson & Johnson (J&J) has dropped its lawsuit against South Korean biosimilars maker Samsung Bioepis for infringing patents on the company’s blockbuster immunology drug Remicade (infliximab).

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Judge denies attempt to dismiss pay-for-delay class action

Home/Pharma News | Posted 08/12/2017

A federal judge ruled on 3 November 2017 against a motion by three drugmakers to shut down antitrust litigation involving the Lidoderm (lidocaine) pain patch.

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Merck KGaA and Samsung BioLogics extend strategic alliance

Home/Pharma News | Posted 01/12/2017

German drugmaker Merck KGaA (Merck Group) announced on 1 November 2017 that it had signed a ‘Memorandum of Understanding (MoU) with Samsung BioLogics for a strategic alliance on biopharmaceutical manufacturing and biologic[al]s process development’.

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Amneal and Impax combine to create 5th largest US generics company

Home/Pharma News | Posted 03/11/2017

US generics makers Amneal Pharmaceuticals (Amneal) and Impax Laboratories (Impax) announced on 17 October 2017 that they had entered into a definitive deal to combine the two companies.

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Synthon prevails over Copaxone patent dispute

Home/Pharma News | Posted 13/10/2017

On 13 September 2017, the Technical Board of Appeal (TBA) of the European Patent Office (EPO) revoked the patent for Teva Pharmaceutical’s (Teva) synthesis of the active ingredient in Copaxone, a key drug used to treat recurring multiple sclerosis (MS). The case against Israel-based Teva was filed by the Netherlands-based generics and biopharmaceuticals company Synthon BV, who is now clear to market their generic glatiramer acetate in a number of European countries.

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Amgen and Simcere to collaborate on copy biologicals in China

Home/Pharma News | Posted 06/10/2017

Biotech giant Amgen and China-based Simcere Pharmaceutical Group (Simcere) announced on 26 September 2017 that they have made an exclusive agreement to co-develop and commercialize four copy biologicals in China.

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Fresenius Kabi acquires Merck KGaA’s biosimilars business

Home/Pharma News | Posted 15/09/2017

Fresenius Kabi, one of the independently operated business segments of global healthcare group Fresenius, announced on 1 September 2017 that it had ‘successfully closed the acquisition of Merck KGaA’s biosimilars business’.

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Generics in Greece most expensive in the EU and uptake remain low

Home/Pharma News | Posted 18/08/2017

Despite being one of Europe’s poorest countries, Greece continues to spend on expensive patented drugs and only a quarter of medicines prescribed in the country are generics, according to recent analysis by Politico.

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Daiichi Sankyo ends deal with Coherus for etanercept biosimilar in Japan

Home/Pharma News | Posted 14/07/2017

Daiichi Sankyo announced on 5 July 2017 that it was ending its co-development in Japan with Coherus BioSciences (Coherus) of a biosimilar to Amgen’s arthritis drug Enbrel (etanercept).