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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.

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’.

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

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.

Synthon prevails over Copaxone patent dispute

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.

Amgen and Simcere to collaborate on copy biologicals in China

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.

Fresenius Kabi acquires Merck KGaA’s biosimilars business

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’.