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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 received 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.

Biocon and Sandoz join forces for global next-generation biosimilars

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.

Top 10 most read GaBI Online articles in 2017

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.

J&J drops lawsuit against Samsung Bioepis over Remicade biosimilar

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).

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

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.

Merck KGaA and Samsung BioLogics extend strategic alliance

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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