FiercePharmaAsia—Gilead’s API lawsuit, Biocon plant concerns, AstraZeneca’s Chinese business

A whistleblower lawsuit alleging that Gilead used an unapproved API from China in top HIV meds was revived by an appeals court.

Welcome to this week's FiercePharmaAsia report, which includes stories about a revived whistleblower lawsuit against Gilead, plant issues that delayed approval of Biocon and Mylan's Herceptin biosimilar in Europe, AstraZeneca's investment in its Sydney plant to meet rising respiratory demands in China, and more.

1. Gilead faces revived lawsuit claiming it sidestepped FDA with HIV drug imports

A whistleblower lawsuit has come back to haunt Gilead Sciences. An ex-employee couple accused Gilead of using a not-yet-FDA-approved active ingredient from China in three top HIV meds—Emtriva, Truvada and Atripla—for 16 months starting in December 2007. The former employees also allege that Gilead fired one of them because he fought the company’s actions.

2. Biocon and Mylan Herceptin biosimilar stalled in EU over plant issues

Biocon and Mylan will have to wait a while before their Herceptin biosimilar can be approved in Europe. The duo has already obtained an approval in India, but the European Medicines Agency is holding off, citing issues with Biocon’s Bangalore plant after an inspection by the French authority in March. The delay could yield the duo’s current lead to Samsung Bioepis, which is just weeks behind with its version.

3. AstraZeneca, spurred by China’s respiratory demands, expands Australian plant

Sales of AstraZeneca’s asthma treatment Pulmicort have been increasing significantly in the past two years in China, reaching $570 million in 2016, and the British pharma is ramping up production by pouring about $77 million to add three lines to its Sydney site. The addition would boost exports from the site—the majority of which are shipped to China—to about $1.8 billion over the next four years.

4. GSK plant in India to open in 2018

GlaxoSmithKline is about to finish its new manufacturing plant in India. The $155 million plant and warehouse is slated to begin production in 2018 and will be able to make 8 billion tablets and 1 billion capsules a year for the Indian market. GSK is also investing about $75 million in a plant in Nashik to expand its thyroid and dermatology offerings.

5. FDA slams Indian drugmaker for using rusty equipment

The FDA issued a warning letter to India’s Vista Pharmaceuticals after an inspection last year found it was using rusted equipment and producing meds that had never been validated. The checkup was prompted by a complaint about metal embedded in its drug. The agency is asking Vista to do a retrospective review of all medications produced with the old equipment.