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Amneal and mAbxience make deal for bevacizumab biosimilar

US generics maker Amneal Pharmaceuticals (Amneal) and biosimilars specialist mAbxience, a subsidiary of Spanish healthcare firm Insud Pharma (formerly the Chemo Group), announced on 23 May 2018 that they have signed an exclusive licensing and supply agreement in the US for mAbxience’s candidate bevacizumab biosimilar.

Strides and Apotex to merge Australian generics businesses

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.

Sanofi to sell Zentiva generics arm to Advent

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.

Mylan and Fujifilm Kyowa Kirin Biologics partner on adalimumab biosimilar

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.

Fujifilm to acquire cell culture media companies

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.

Stada resubmits biosimilar pegfilgrastim but stops adalimumab development

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.

Korea’s CJ Healthcare shares biosimilar technology with China

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].

Biosimilar deals for Hikma and Lupin

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).

Mylan and Revance team up for botox biosimilar

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).

MENA region biologicals maker CinnaGen receives EU GMP certification

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.