The AAM has warned the Trump administration that ‘Buy American’ requirements on medicines could limit patient access to affordable medicines and increase the risk of drug shortages during the coronavirus pandemic.

Shanghai Henlius Biotech has announced that China’s NMPA has accepted the firm’s filing for its HLX14 denosumab biosimilar. Meanwhile, the company has also announced dosing the first patient in a Phase II clinical trial of its novel HLX10 anti-PD-1 monoclonal antibody.

Biocon has reported FDA clearance for its Malaysian insulin facility, while Lupin and Xellia have also received plant approvals. Meanwhile, Alembic has seen mixed fortunes, receiving both Form 483 observations and an EIR.

The AAM has outlined a set of principles that it says will help protect patient access to generics and biosimilars and aid in efforts to diversify the supply chain to help mitigate future crises. The association said it would work with policymakers and other stakeholders to formulate policies to address concerns that the coronavirus pandemic has raised.

Celltrion has accelerated the development of its antiviral treatment for COVID-19 and aims to launch a rapid self-testing kit that could provide results within 15-20 minutes. The Korean firm also plans to develop a ‘super antibody’ to prepare for potential future pandemic situations.

Despite the delay in a New York state opioid trial due to coronavirus, a motion has been filed to remove Mallinckrodt and SpecGx from proceedings. However, Nassau County opposed the motion.