Asia Regulatory Roundup: China's New Biosimilars Guideline and Price Controls (10 March 2015)

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Lifting of Chinese Price Controls Brings Mixed Blessings

China says it will stop capping the prices of drugs, ending a situation in which companies lived in fear of unilateral cost cutting actions by the government. However, experts say they doubt the new model will be a panacea, with a new set of issues and pricing pressures expected to replace the current concerns. 

Chinese officials are yet to set a timetable for the lifting of the cap or provide specifics of the plan, the Wall Street Journal reports. The basic model has taken shape, though. Instead of setting prices centrally, China will effectively devolve powers to local governments. Manufacturers will go through a regional bidding system to win contracts and then may negotiate prices with hospitals and local social security bodies.

“Pricing pressure will remain high,” Helen Chen, a partner at consultancy L.E.K., said. Some expect prices to fall over time, but such shifts will be driven more by free market forces than centralized government decisions. Companies may respond with the tactics they apply in other free markets, such as branding to differentiate their products. Businesses must also adapt to new ways of selling, notably through the online channels that some see as a trigger for this week’s lifting of price caps.  

Wall Street Journal

DCGI Posts Draft Accreditation Standards for Clinical Trial Sites

The Drugs Controller General of India (DCGI) has released draft standards for the accreditation of ethics committees, investigators and clinical trial sites. DCGI drafted the document to facilitate the move toward only conducting clinical trials at sites that have been shown to meet certain standards.

If the draft standards come into force, trial sites will need to show they have adequate infrastructure, facilities and documented processes to run safe, ethical studies. The draft is a tweaked version of the text released by the National Accreditation Board for Hospitals and Healthcare Providers (NABH) late last year. DCGI is accepting feedback on the draft until early April. Officials had originally hoped to make accreditation mandatory in January.

The regulator released the document alongside a draft application form for accreditation, which details the fees and inspections associated with the process. A hospital with three investigators and two sites of different specialties would pay around $320 to apply for accreditation and an annual fee of $800. The assessment would take two days and be followed the next year by a one-day surveillance visit. Once approved, the accreditation is expected to last for three years.  

DCGI Notice I Draft Standards I Draft Application I PharmaBiz

CFDA Finalizes Biosimilars Guidance

The China Food and Drug Administration (CFDA) has released the final version of its biosimilars guidance. Authorities have made a handful of notable changes to the document since a draft version was released in November.

Law firm Ropes & Gray has published a summary of the major revisions to the guidelines. Four of the five changes picked out in the summary are tweaks to sections that were already in the draft. The final version clarifies that biosimilars will follow the new drug approval pathway and are defined as being similar to reference products approved in China or overseas. In the original draft, CFDA made no mention of where the reference product must be approved.

Other changes in the final version include an expanded definition of reference products — which states they must be approved in China before trials of the biosimilar start — and the dropping of the need to choose at least three batches for comparative tests. The final text also includes a new line stating manufacturers should source samples used in comparative tests from the same production plant.

Ropes & Gray I CFDA Notice (Chinese)

DRAP Seeks Public Feedback on Drug Prices and Quality

The head of the Drug Regulatory Authority of Pakistan (DRAP) has made the opening of a public consultation on the quality and price of medicines one of his first acts in the role. Quality and price have dominated regulatory discussions in Pakistan in recent months, and Dr. Mohammad Aslam now wants to include the public in the conversation.

Aslam is encouraging people to communicate any concerns they have about the medicines they take and what they pay for them to DRAP. The start of the consultation coincided with news that Gilead has agreed to supply Sovaldi at 30% below the price set by the regulator. Gilead will supply Sovaldi to its local distributor for around $13 a pill, $6 less than the ceiling put in place by DRAP. Sovaldi is due to be available within six weeks.

While Gilead has voluntarily dropped its price, other companies are pushing DRAP to raise the limit on what they can charge. Aslam told the Associated Press of Pakistan DRAP will settle any requests to increase prices within 90 days. If DRAP fails to act within that period, companies can start charging up to 8% more for the product.

Associated Press of Pakistan I Daily Times

China Starts 22-Month Campaign Against Food and Drug Crimes

China’s Supreme People’s Procuratorate (SPP) has begun a 22-month crackdown on crimes related to food, drugs and the environment, state news agency Xinhua reports. The campaign gets underway this month and will prioritize the punishment of people selling fake and substandard food and drugs.

SPP is particularly keen to target officials who enable the sale of such products, either inadvertently or because of bribes. The last clampdown by SPP — which started one year ago and ran for eight months — identified 290 officials who were suspected of trying to hide crimes.

The new initiative will remain active until December 2016, by which time SPP hopes to have made a major dent in the networks that perform and enable food, drug and environmental crimes.

Xinhua I FoodQualityNews

Sri Lanka Nears Mandatory Prioritization of Generics

Sri Lanka is set to make it mandatory for physicians to prescribe a generic whenever one is available for the indication being treated. The government is keen to fast-track implementation of the law, which was passed by parliament late last week.

Doctors must now write the generic name for medicines on prescriptions, potentially steering patients away from more expensive branded drugs, The Sunday Times reports. The policy is part of a wide-ranging rethink of the Sri Lankan medical industry and its regulator.

Sri Lanka is to create a 13-member regulatory authority to handle licensing, manufacturing and other oversight tasks comparable to those handled by its peers around the world. The overarching goal is to ensure a supply of safe, affordable and effective medicines that adhere to quality standards.

The Sunday Times I NewsFirst I FiercePharmaAsia

Other News:

Jiangsu Food and Drug Administration (JFDA) is to review a new drug application from Eisai for the Alzheimer’s disease drug Aricept. The acceptance of the application for review moves Eisai one step closer to expanding the label for Aricept in China to include patients with severe forms of Alzheimer’s. Currently, Aricept is approved for mild to moderate Alzheimer’s in China. Press Release

Incepta Pharmaceuticals has started selling a copy of Gilead Sciences’ Sovaldi in Bangladesh for $10 a pill. The drugmaker is able to sell the product without a license from Gilead because Sovaldi lacks patent protection in the country. Incepta hopes to expand sales into other countries in southeast Asia and Africa. Natco Pharma has also begun selling a Sovaldi copy in Nepal. Bloomberg I The Hindu