Regulatory Focus™ > News Articles > Asia Regulatory Roundup: Australia Recommends First Pharmacy-Level Substitution of mAb Biosimilar (2

Asia Regulatory Roundup: Australia Recommends First Pharmacy-Level Substitution of mAb Biosimilar (25 August 2015)

Posted 25 August 2015 | By Nick Paul Taylor 

Asia Regulatory Roundup: Australia Recommends First Pharmacy-Level Substitution of mAb Biosimilar (25 August 2015)

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

Australia's PBAC Recommends Allowing Pharmacy-Level Substitution of mAb Biosimilar

Officials in Australia have set the stage for a pair of firsts by registering a biosimilar monoclonal antibody (mAb) and recommending it for pharmacy-level substitution. The decisions mean Hospira's Remicade copy is set to be both Australia's first biosimilar mAb and its first substitutable biological copycat.

Australia's Pharmaceutical Benefits Advisory Committee (PBAC) has cleared the path for Hospira's drug, Inflectra, to be substituted for Remicade by awarding it "a" flagged status. The recently created "a" flagging system allows the substitution of drugs that meet certain standards. While the plan has received criticism, leading to a reworking of its methodology, Australia is pushing ahead as it looks to biosimilars to generate savings for its Pharmaceutical Benefits Scheme (PBS)

PBS spent AU$100 million ($73 million) on Johnson & Johnson's rheumatoid arthritis blockbuster Remicade last year. In a release to detail the registration news, Hospira talked up the potential for its copy to cut costs without going into the specifics of its pricing. The only figures mentioned were the general expectation that biosimilars will knock up to 30% off the price paid for drugs and PBS' ambition to save AU$880 million over the next five years by switching patients to copies of mAbs.

Press Release, PharmaDispatch

Report: DCGI Panel Open to Allowing Online Drug Sales

Members of a subcommittee set up by the Drugs Controller General of India (DCGI) are open to allowing the sale of prescription medicines online, The Economic Times reports. The news bodes well for the likes of Amazon and Flipkart, which stand to profit if regulators open up the online drug sales market.

DCGI set up the subcommittee in the wake of raids by Maharashtra Food and Drug Administration (FDA) on the online retailer Snapdeal earlier in the year. The raids led to allegations that Snapdeal was providing a platform for the illegal sale of prescription medicines, but also prompted India to rethink how it should regulate online sales of drugs. This rethink now appears likely to lead to an easing of restrictions on online retailers. 

"Drug controllers of many states have submitted their proposals to the government. Majority members of the sub-committee are in favor of considering the pleas of trade bodies, pharmacy chains and e-tailers to allow online sale of medicines with adequate safeguards taking into account the global practices," an anonymous member of the DCGI panel said. Akun Sabharwal, director of Telangana's Drugs Control Administration, is among those in favor of allowing online sales.

The Economic Times

Pakistan Bows to Pressure to Review Regulatory Amendments

Chief Minister of Punjab Shahbaz Sharif has agreed to reconsider regulatory changes after the Pakistani pharma industry threatened to stop production in protest of the amendments. Shahbaz is setting up a committee of government officials, industry representatives and scientists to consider the topic.

While nothing is finalized yet, the backing down by Shahbaz represents at least a temporary victory for the Pakistan Pharmaceutical Manufacturers Association (PPMA), which was incensed by the proposed changes. The criticisms centered on punishments for producing substandard drugs, which PPMA felt were too harsh and conflated genuine mistakes with deliberate deception. Khawaja Shahzeb Akram, a representative of PPMA, went as far as to call the proposals tyrannical, Business Recorder reports.

"Giving registered firms and those doing business of spurious drugs same treatment is unjustified and is against all norms of justice," he said. PPMA will now have an opportunity to argue its case and push for changes that balance Shahbaz's desire to clamp down on spurious drugs with its need to protect legitimate manufacturers. In giving PPMS such an opportunity, Shahbaz has staved off a shutdown that would have caused drug production in Pakistan to slow to a crawl.

Business Recorder, The Nation

India Taking Legal Advice as Spat over EMA Ban Continues

Reports that India was ready to work out its differences with Europe appear to be premature. While the message coming out of India last week was conciliatory, the commerce secretary has now said the government is seeking legal advice in an attempt to overturn the European ban on drugs tested by GVK Biosciences.

India has considered and taken multiple actions in response to the European ban, from threatening to take the case to the World Trade Organization to actually deferring talks over a trade deal. Last week an anonymous official said the deferral was a temporary measure, but, in public at least, the government is showing no signs of being willing to let the matter drop. The goal is still to return the GVK Biosciences-tested products to the shelves of European pharmacies. 

"We are certainly exploring what are the options for India. We are taking legal advice. We will take a call on this to move forward," Commerce Secretary Rita Teaotia told the Press Trust of India. So far, officials in Europe appear unmoved by the pressure being applied by India. The European Medicines Agency (EMA) ban remains in place and member states are enforcing the punishment. Germany suspended the licenses of 54 drugs tested by GVK this week.

Press Trust of India, More

Bangladeshi Court Pursues Last Company in Toxic Paracetamol Case

A court in Dhaka, Bangladesh has scheduled a hearing for another case involving contamination of paracetamol with diethylene glycol. The fixing of a Sept. 6 start date for the hearing moves the court a step closer to wrapping up a clutch of legal cases that date back to 1993.

Officials at the Bangladesh Directorate General of Drug Administration (DGDA) brought a case against Polychem at the start of 1993, only for its progress to be halted by a stay order the following year. The managing director and four others involved with the now-defunct firm have been on bail ever since. Now, more than 20 years after the events at the center of the case, the five accused have been ordered to present themselves at the court, The Daily Star reports.

The resumption of the case follows shortly after the court reached a verdict against employees of BCI who were also accused of being involved with the use of diethylene glycol. With the BCI case coming to a conclusion, Polychem is now the only one of the five companies whose products tested positive for diethylene glycol that is still awaiting a ruling. Employees of Adflame Pharmaceutical were convicted in 2014, while the owners of Rex Pharma were acquitted in 2003.

The Daily Star

Other News:

A task force set up by the Department of Pharmaceuticals in India has called for the government to review the Drug Price Control Order, 2013. The task force identified "genuine practical problems of implementation" during its assessment, prompting it to recommend that the government takes a look at whether the application of the law can be improved. PharmaBiz

The Indian Commerce Ministry is considering setting up a think tank to tackle problems that are holding back pharmaceutical exports. Government officials, private sector companies and scientists would sit on the think tank, giving the ministry access to the breadth of expertise it thinks is needed to find a way to resolve bottlenecks that exist today. Press Trust of India

Scientists in Pakistan have bemoaned the lack of World Health Organization-accredited drug testing laboratories in the country. Dental News


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