Welcome to this week’s FiercePharmaAsia report, which includes stories about the seven FDA warning letters India's Wockhardt received, the China FDA chief's promise to build a more foreign-drug-friendly approval process, two patent lawsuits regarding copycats of Roche's Herceptin and two on-patent Bayer blockbusters, and more.
The FDA is gradually losing patience with Wockhardt as the Indian drugmaker amassed seven warning letters from the agency. In the latest letter, the FDA savaged the Indian company for repeated and persistent manufacturing failings across its manufacturing network. Besides that, the FDA also issued an untitled letter in January to the company’s new sterile injectables plant for basically the same types of shortcomings.
During China’s annual national congress meetings, China FDA chief Bi Jingquan promised to tackle some of the major drug approval barriers before foreign biopharma companies. That includes eliminating unreasonable regulations, hiring more staff and revamping procedures at the Center for Drug Evaluation to speed up the drug approval process, and better implementation of intellectual property laws.
3. Mylan and Biocon finally win right to sell Herceptin biosim in India even as they have taken it to U.S. and EU
In a disappointment to Roche, the Delhi High Court ruled that Mylan and Biocon have the right to sell their versions of a Herceptin biosimilar in India. The two partners first got approval for that biosimilar three years ago in India and are currently forging ahead with seeking approvals in the U.S. and EU.
4. As U.S. rep eyes global IP, India lets local pharmas export copies of on-patent Bayer blockbusters
The Delhi High Court made another ruling that allows Indian drugmakers Natco Pharma and Alembic Pharmaceuticals to export their copies of two on-patent Bayer blockbusters, Nexavar and Xarelto, respectively. The rulings come as multiple parties urge the U.S. Trade Representative to reprimand particular IP offenders around the world.
A recent Frost & Sullivan report on the Asian CRO market suggests that the region could see that business grow at a compound annual growth rate of about 20% by 2020. The key trait of Asia is its large population based in urban areas, which could be a huge boost for patient recruitment, a key factor that affects the cost and results of clinical trials.
India’s largest drugmakers are making a case through a report that the U.S. should import cheap Indian-made drugs to hold down healthcare costs and partner with its pharma leaders to develop inexpensive biosimilars. But Indian pharma companies have a less-than-stellar track record with the FDA on manufacturing quality.
Several Chinese companies have been approved to study their H7N9 vaccines on humans, but after the CDC examined viruses from a globally shared database, it found that viruses in the current fifth epidemic in China might not be susceptible to available vaccine candidates. The CDC is now working on a new one based on a low pathogenic strain of the virus.
Hong Kong-based BeiGene, which is developing a portfolio of immuno-oncology drugs it expects will challenge those of Western drugmakers, has struck a deal with a development agency in Guangzhou, China, to form a JV and build a pharmaceutical manufacturing facility in the city. The JV will invest a total of RMB2.2 billion ($330 million) in the project.
After China's high-profile vaccine scandal was exposed, the government sentenced Pang Hongwei, the key participant in the crime ring, to 19 years in prison and updated its supply chain regulations. But in an open letter to China's congress, some lawyers said they want to see more stringent rules on vaccine supply chain management, plus better storage and administration requirements.
India’s Megafine Pharma has received its second FDA warning letter in 10 months, this one for an API intermediates plant in India, mainly for faking data. The agency had banned a Megafine API plant in Lakhmapur, Nashik, in 2015 and then followed that up with a warning letter in May of last year.