Asia Regulatory Roundup: Australia’s TGA Rejects Suffixes for Biosimilar Names

Regulatory NewsRegulatory News | 30 January 2018 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Rejects use of Biosimilar Suffixes Despite Pharma Support for Naming Convention
The Therapeutic Goods Administration (TGA) has rejected the idea of using suffixes to differentiate biosimilars from reference products. Pharma trade group Medicines Australia backed the suffix-based model during a recent TGA consultation, but the agency concluded it would create “complexity and potential confusion.”
Suffix identifiers were the backbone of one of the four options proposed by TGA in a consultation on the naming of biosimilars. The other options were to adopt a barcode system similar to that used in the European Union, encourage the inclusion of trade names in adverse event reports or stick with the status quo. TGA asked for feedback on each of the options. Having analyzed the responses, TGA has established its position.
“Feedback informed the government's decision to ... continue using the Australian biological name — without a specific identifier suffix — and strengthen our adverse event reporting,” TGA wrote in its response to the comments.
TGA is sticking with the status quo in terms of naming, but is bolstering its oversight of biosimilars by implementing one, possibly two, of the other options. Plans to adopt the option on the use of trade names in adverse event reports are most advanced. TGA will make it mandatory to include the trade name of a product in adverse event reports. This will enhance TGA’s ability to differentiate between safety issues that are specific to a product and those that apply to an active ingredient in general.
The agency is making this the centerpiece of its near-term biosimilar strategy. TGA is yet to rule out adopting EU-style barcodes at a later date, though, and its response to the feedback notes its initial position does not preclude it doing so.
That puts TGA’s position somewhere between three of the options it proposed. The only option that the agency ruled out conclusively is the use of suffixes. TGA adopted this stance to avoid the “complexity and potential confusion that would be associated with introduction of a suffix-based system with retrospective coverage.”
Parts of the industry are more amenable to the suffix system. Medicines Australia, a large pharma trade group, advocated for the adoption of suffix identifiers in its feedback to TGA. The group is in favor of including trade names in adverse events, but thinks this will prove insufficient.
“Familiarity with originator brand names may lead to inadvertent misattribution to the originator product and undermine the desired objective to improve the quality of the captured data,” Medicines Australia wrote, citing a study by Amgen to support its case.
This argument failed to sway TGA, which concluded its approach will achieve its aims without imposing labeling requirements and associated costs on the industry. TGA will provide further details of its policy in the coming months.
TGA Response, Medicines Australia Feedback
Sanofi Criticizes Inconsistency of TGA’s Proposed Assessment Timeframe, Fee Structure
Sanofi has criticized planned changes to Australian complementary medicines assessment pathways. TGA thinks the changes are improvements to its business processes, but Sanofi found fault with the assessment timeframe and fee structure put forward by the agency.
The criticism centers on a comparison between the proposed timeframe and fees and those already in place for over-the-counter (OTC) medicines. To make its case, Sanofi sent TGA a table comparing current and proposed complementary medicine fees with those the regulator charges for OTC drugs. The comparison reveals some sizable differences in the fees for applications Sanofi sees as similar.
All but one category of registered complementary medicines are associated with higher fees than the OTC classifications Sanofi picks as comparators. For example, the total cost of the application and evaluation of RCM5 complementary medicines — completely new active ingredients never evaluated for safety, quality and efficacy — is AU$ 38,270 ($30,940).
That is 43% more than TGA charges for OTC drugs that feature new active ingredients. The difference between the fees for the three next highest classes of complementary medicines ranges from 69% to 213% more than the comparable category of OTC medicines. Sanofi thinks this is a problem.
“Comparison with the evaluation timeframes and fees for registered OTC medicines indicates there is no consistency between timeframes and the total cost of the application,” the company wrote in its feedback to TGA. “We propose the fees and timeframes are re-evaluated to correct this inconsistency.”
TGA’s response listed the fee structure as an area that it is changing in response to the feedback but lacked details. The agency said the fees will be “aligned with the costs of providing evaluation services.”
Sanofi was otherwise broadly supportive of the TGA proposals. The other main point of divergence relates to the criteria TGA is proposing to use to select sources of evidence for de novo assessments. TGA wants to limit the sources to English documents. Sanofi thinks TGA should accept translations.
Sanofi Feedback, All Reponses
CDSCO Moves to Strengthen Leadership, Research Abilities of Medical Device Unit
The Central Drugs Standard Control Organization (CDSCO) is recruiting for a  drugs inspector, medical devices. Drugs inspector is one of the top positions within CDSCO’s medical device unit.
CDSCO described the job as being “on a deputation basis,” adding that deputations typically last less than three years. The agency is hoping to appoint someone who is already employed at the same level, or who has considerable experience at a slightly lower rung. The organization chart for CDSCO’s medical device unit currently lists four drugs inspectors.
CDSCO posted the advert the day before releasing a list of candidates for medical device research scientist positions it is trying to fill. The agency is interviewing 39 candidates.
The hirings position CDSCO to add to its medical device capacity during a period of change for the regulation of the sector. The Medical Device Rules India, 2017 came into force at the start of the year.
Job Advert, Research Candidates
CFDA Streamlines Initiation of Legal Proceedings Against Violators of Drug Rules
The China Food and Drug Administration (CFDA) is tweaking its approach to the initiation of legal proceedings. CFDA is proposing to swiftly transfer evidence of violations to law enforcement officials and expects to receive their assessments of the strength of the evidence similarly quickly.

Setting deadlines for the sharing and evaluation of evidence — and stipulating what materials should be shared — is intended to lessen the disconnect between CFDA and the bodies that pursue legal cases against people who violate food and drug rules. If the changes work as hoped, evidence of wrongdoing discovered by CFDA should more quickly translate into legal action.
The agency shared the timeframes as part of a document that covers multiple aspects of the legal actions China can bring to bear against those who break its rules. The document addresses CFDA’s powers to ban people from holding positions in the drug industry and the need to monitor whether the enforcement system is working effectively.
CFDA Policy (Chinese)
Other News:
TGA has denied reports it is considering banning doctors from prescribing high-dose opioids. The agency included controlling access to certain products in a list of the potential actions it could take to curb the opioid crisis. This led to a media report that suggested TGA would stop doctors accessing high-dose opioids. TGA called the report “totally incorrect.” TGA Statement


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