FDA approval for Amgen’s infliximab biosimilar Avsola

US-based biotech giant Amgen announced on 6 December 2019 that it had received approval from the US Food and Drug Administration (FDA) for its infliximab biosimilar Avsola (ABP 710).

Canadian gastroenterologists issue biosimilar position statement

The Canadian Association of Gastroenterology (CAG) and Crohn’s and Colitis Canada announced on 24 October 2019 that they had issued a joint position statement on the use of biosimilars for the ...

Bio-Thera gains Chinese approval for adalimumab copy biological and starts ustekinumab trial

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) has approved Qletli, an adalimumab copy biological. The NMPA has also approved the ...

Bill to stop misuse of Citizen Petitions advances in the House

On 13 November 2019, the House Energy and Commerce’s health subcommittee unanimously advanced a bipartisan bill aimed at preventing companies from using citizen petitions to delay the approval of ...

The impact of generics regulation in Brazil

Sales of originator drugs have decreased and the number of generics manufacturers have increased following the introduction of the Brazilian Generics Law, reports a new study [1].