Several Eastern European generics companies achieved sales growth in 2018. Looking ahead, Grindeks plans to strengthen its presence in Russia and other CIS countries, Alkaloid is set to continue investing in production facilities and technologies, while Olainfarm looks to upgrade its product dossiers.

Zentiva has signed its first acquisition after it was carved out from Sanofi last year to become an independent company, entering into a shared purchase agreement with Siyiara to acquire Romania-based food supplement and OTC medicines producer Solacium.

Pfizer’s approval for trastuzumab in the US marks the fourth FDA nod for a biosimilar rival to Genentech’s Herceptin original. However, while two of those biosimilar sponsors continue to be engaged in patent litigation with the originator, Pfizer and Mylan have both struck settlement deals.

Off-patent industry association Medicines for Europe is one of several European pharmaceutical associations to have lent their backing to the latest European Commission strategic approach to pharmaceuticals in the environment.

Association for Accessible Medicines' Davis tries to counter concerns that the long-stalled measure would incentivize lawsuits against brand companies; witnesses at a House subcommittee hearing on drug pricing legislation also testified that the BLOCKING Act would create an overly broad and complicated framework for triggering 180-day exclusivity.

Pfizer’s approval for trastuzumab in the US marks the fourth FDA nod for a biosimilar rival to Genentech’s Herceptin original. However, while two of those biosimilar sponsors continue to be engaged in patent litigation with the originator, Pfizer and Mylan have both struck settlement deals.

Venipharm has received approval for its enoxaparin through the European decentralized procedure. The product was developed in collaboration with China’s Nanjing King-Friend Biochemical Pharmaceutical.

In the face of calls from the biosimilars industry to rethink its position on biological naming conventions as being out of step with other major territories, the FDA has issued fresh guidance that reinforces its commitment to using four-letter suffixes for both biosimilars and new brand biologics, as well as confirming that the names of any biosimilars designated as ‘interchangeable’ will bear a suffix. At the same time, the agency has rowed back on previous proposals to retroactively add a suffix to already-licensed biologics.

Alvogen’s inter partes review petition challenging a Revlimid patent in the US has been denied by the PTAB, following similar denials of petitions by Dr Reddy’s over three other Revlimid patents.

Off-patent industry association Medicines for Europe is one of several European pharmaceutical associations to have lent their backing to the latest European Commission strategic approach to pharmaceuticals in the environment.

Off-patent industry association Medicines for Europe is one of several European pharmaceutical associations to have lent their backing to the latest European Commission strategic approach to pharmaceuticals in the environment.

Data revealed by Korea’s Celltrion demonstrates that the firm’s subcutaneous infliximab is comparable to the intravenous formulation, with a study showing that auto-injection is a viable administrative method.

After the CHMP last month refused to recommend granting approval for TLC’s doxorubicin hybrid, the firm has asked the committee within the EMA to revisit its opinion.