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Biosimilars - MYTH vs. FACT

For more than a decade, BIO has called for open, transparent, and science-based dialogue regarding biosimilars. More recently, we played a leading role in the effort to establish a pathway for the approval of biosimilars. Many of our members are global leaders in the development and commercialization of biosimilars.

MYTH

 

FACT

BIO has been highly critical of the FDA’s approach to biosimilars.    Our goals with respect to the introduction of biosimilars into the marketplace are the same as FDA’s goals – to ensure patient safety and enhance access to biological medicines, whether innovative or biosimilar versions. We must ensure that sound science prevails and our common objectives are achieved.

 

Assigning different names to innovator biologics and biosimilars would undermine the projected savings to the public health care system once biosimilars are introduced to the marketplace.
Proposing different names is really just a gambit designed to blunt competition before biosimilars become an integral part of the US health care market.
Giving biosimilars names that are different from their brand counterparts would likely compromise the ability of biosimilars to succeed in the marketplace.
  A key consideration in the debate on the naming of biosimilars is competition between innovative biologics and biosimilars.  However, as leading scientific and regulatory authorities around the world have universally determined, treating biosimilars like generic drugs is inappropriate because biosimilars are not the same as their reference biologics. 
The introduction of biosimilars into the marketplace raises novel and complex questions of science and law, and requires the updating of legal and regulatory frameworks to ensure, among other things, accurate product identification.  A naming convention that ensures distinguishable product identification will help to prevent inappropriate substitution, facilitate postmarket surveillance of drug safety, ensure accurate attribution of adverse events to the right product, and support tracing of products in the event of the need to recall. 
Assigning distinguishable nonproprietary names or identifiers for all biological products will not compromise the ability of biosimilars to succeed in the marketplace.  In fact, existing biosimilar markets that use distinguishable brand and nonproprietary names, within the International Conference on Harmonization regions, are proving robust.

 

The National Drug Code or the active ingredient name can be used to track adverse events.   The NDC – a 10-digit numerical code – cannot possibly serve the function of a distinct name. Reporting of adverse events by NDC is highly likely to involve error. NDCs are not used in all practice settings, and are not commonly used in physician offices or the inpatient setting. Use of multiple systems to identify products is critical for ensuring patient safety. FDA has commented publicly on more than one occasion that reliance on the NDC for pharmacovigilance is not a good idea.

 

A different name will lead prescribers to think that a biosimilar has a different mechanism of action from a brand drug, in other words, a different naming convention will introduce uncertainty in the mind of the prescriber and provide a disincentive to use a biosimilar.

 

  A distinct name is not the same as a wholly different name. Rather, it could consist of a common stem to permit science-based associations among products and a qualifier to permit identification. With appropriate education, such a naming system would provide prescribers with greater clarity and confidence in prescribing, not less.
Physicians want higher-priced biologics since they are reimbursed at a higher rate – 6% on top of the average purchase price.

 

  The ACA included a provision spelling out biosimilar reimbursement to explicitly deal with that exact issue – the 6% operational cost add on for the biosimilar is 6% average innovator’s price, not of the biosimilar’s price. Therefore, the add on is identical for both innovator biologics and biosimilars.
Innovator biologic manufacturers may make changes to the way products are manufactured. The product may change – a process termed ‘product drift’ – and regulators require that manufacturers demonstrate that the new product is comparable to the original biologic. When regulators determine the new product is comparable to the original, the brand manufacturer gets to use the same International Nonproprietary Name (INN). It is illogical to argue for a different INN for a biosimilar but keep the same INN for a brand biologic produced by a different process.   Product drift supports the need for distinct naming to ensure that prescribers and patients are informed that biosimilar products are not identical to the reference product, both at the time of approval and throughout the lifecycle of the product. The demonstration of comparability before and after a manufacturing change by the same manufacturer is a contextually different exercise from the establishment of similarity between two products made by different manufacturers using different cell lines, manufacturing processes, facilities and equipment. A comparability assessment for intra-manufacturer changes is performed to confirm the established safety and efficacy profile of a marketed biological product after well-defined, incremental process changes are made, taking into consideration an extensive process and product history linked to clinical experience. A biosimilarity assessment is performed to establish the safety and efficacy profile of a biosimilar product derived from an independently designed manufacturing process where no process history exists and a link to clinical experience has yet to be established. By default, this assessment requires comparative quality, pre-clinical and clinical data with a reference product. Therefore, it is entirely consistent to argue that a comparable product produced by the same manufacturer retains its INN, while a similar product produced by a different manufacturer should not share an INN with the reference product.