Updated on 24 July 2012
The DRA then requested for clinical trial data to demonstrate efficacy and safety of the individual biosimilar product, as the amino acid sequence of the originator and biosimilar in most instances are not identical. As such, mere analysis as per pharmacopeial standard or even bio equivalence studies may not be adequate to demonstrate efficacy and safety of the individual molecule.
Mr Adrian Basnayake says, "Some principals have been able to submit the requested data, which is clinical trial data and bio equivalence data, although there have been some delay in understanding what the DRA wanted and in sending the requested information. In some instances, the DRA was confused about the difference between biological products and biosimilars, and what is an originator or a biosimilar. Above factors have led to most biosimilars being suspended in registration with effect from March 1, 2012, and consequently they are going out of stock in the market or being disqualified in government tenders. This, no doubt, has impacted the overall health expenditure, whether that expense is met by the government or out of pocket by patients."
Reacting to the developments, the spokesperson of Dr. Reddy's Laboratories, India, comments, "The Sri Lankan authorities issued a recent directive automatically de-registering several similar bio-therapeutic products previously approved, including two of Dr. Reddy's products. These actions are based solely on the authorities employing a new set of regulations, and not based on any safety, efficacy, or quality aspect of the products. Dr. Reddy's is in discussions to evaluate the next steps."
Mr Nimal Dias Jayasinha says, "Manufacturers have begun to provide additional information required, but the lobby of the multinationals is preventing decisive action being pursued upon this matter. Seemingly, the originator products will continue to have a field day until such time as such biosimilars are registered in the given reference countries, a process which could take quite a few years."
"We understand that some manufactures have submitted the requested data and scrutiny of the data is presently underway by a sub-committee comprising pharmacists, pharmacologists and clinicians. We are hopeful that the CDDA will conclude the review of this submitted data expeditiously and some of these biosimilars can be made available to patients in the next two-to-three months. In the mean time, originators are experiencing the best sales in many years," adds Mr Adrian Basnayake.
"My personal view is that the Indian Health Ministry should take this matter up with the WHO, so that rational and reasonable decisions are reached that help benefit the beleaguered patients in Sri Lanka," concludes Mr Nimal Dias Jayasinha.