Govt Looks to Make Biosimilars Accessible Proposes changes to norms to cut the scope of ambiquity & speed up approvals, but move draws mixed reaction from industry bodies
New Delhi: In a move that may improve access to affordable biotechnology-based medicines known as biosimilars, the government has proposed changes to its guidelines to cut the scope for ambiguity and speed up approvals in India. However, a group of multinational pharmaceutical companies has raised concerns over how the move may compromise with the safety of patients.
Biosimilars are copies of complex drugs based on living cells. They are different from chemical-based generic drugs, which are ‘identical’ to the compound used in the original.
The draft of the “Guidelines on Similar Biologics 2016” prepared by the Central Drugs Standard Control Organisation (CDSCO) and the Department of Biotechnology ( DBT) has drawn mixed reactions from industry bodies.
“The 2012 Biosimilar guidelines were largely aligned with global requirements, whereas the proposed revised guidelines suggest dilution of some previous requirements and might potentially compromise patient safety,” Ranjana Smetacek, director general of the Organisation of Pharmaceutical Producers of In- dia, told ET.
On the other hand, local biosimilar companies have taken an optimistic view of the proposals, which includes a key provision that cuts the approval timeline by more than half.
The revised guidelines, if implemented, could reduce the time taken for approving biosimilar drugs to 424 days from 990 days, according to estimates by the Association of Biotech-led Enterprises, a group of local biotech companies.
The body argued that the proposed guidelines would bring more clarity on approval procedures and also ensure higher safety and quality standards. The draft sets the minimum number of patients required for trials and studies in various phases — a detail not identified clearly in the 2012 guidelines, according to ABLE. After approval, companies would have to generate data of the marketed drug over two years to prove it is safe for use in a wider patient base, according to the draft.
“…safety data may need to be collected after market approval through a pre-defined single arm study of generally, more than 200 evaluable patients and compared to historical data of the reference product. The study should be completed preferably within two years of the marketing permission/manufacturing license unless otherwise justified,” according to the draft.
Such revisions raise the bar for biosimilar companies seeking approval for their drugs here, according to ABLE president Panchapagesa Murali. “So far, different companies were getting approval for biosimilar drugs in India with much lower patient data and post-marketing data collection was not objectively defined,” he said.
The 2016 guidelines also clarify conditions for provisions to waive specific trials or reduce the number of patients for certain studies.
“…if the firm conducts pre-approval studies that included more than 100 patients on the proposed similar biologic drug, the number of patients in phase IV study can be reduced accordingly so that the safety data (from both phase III and IV) is derived from a minimum of 300 patients treated with the similar biologics,” the draft said.
The draft proposes that the reference drug used in comparative studies submitted for the product’s approval is licensed and marketed in India and countries that are part of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. The proposed guidelines are up for stakeholder suggestions and comments until April 30, according to a CDSCO notification. ‘Innovator’ product licensed in India or an ICH country (ABLE estimates): Biosimilar drugs could hit the market sooner two years using more than 200 evaluable patients
The 2012 Biosimilar guidelines were largely aligned with global requirements, whereas the proposed revised guidelines suggest dilution of some previous requirements and might potentially compromise patient safety
RANJANA SMETACEK, Within So far, different cos were getting approval for biosimilar drugs in India with much lower patient data and postmarketing data collection was not objectively defined.
DIRECTOR GENERAL, OPPI ABLE PRESIDENT