FDA Biologics and Biosimilars Naming Proposal Draws Criticism

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FDA Biologics and Biosimilars Naming Proposal Draws Criticism

From The Hill: The Food and Drug Administration (FDA) plans to require biotech companies to give Biologics and Biosimilars more specific names, but the plan to add suffixes has drawn criticism across the industry. Recently, the FDA released a draft guidance calling for the addition of suffixes to names of biologics and biosimilars. Biosimilars are similar versions of brand name biologics containing living materials, hence the name. The majority of generics are therapeutically equivalent and thus, substitutable.

While the guidance is not yet in effect, the suffixes would be attached by a hyphen to the “core” name of each biologic product. Biologics and biosimilars share nonproprietary names designated to them by the U.S. Adopted Names (USAN) Council.

Because not all biosimilars are interchangeable, the purpose of the suffixes assists doctors in differentiating between various biologics and biosimilars that may or may not be substitutable. The Federal Trade Commission (FTC) is not a fan of the naming rules and argues that the market for generics and cheaper versions would be affected. The FTC theorizes that due to the suffixes, doctors and health care providers would assume a biosimilar is inferior and would opt for the more expensive biologic. Biologics are expensive; Sovaldi, a Hepatitis C drug runs $84,000 for a 12-week brand name course without insurance.

Drug-makers are on the FDA’s side on this one. Experts argue that biosimilars should be distinguished from the original Biologic because they are not true copies like generics. A biosimilar is similar to that of an already approved biologic and is a highly-similar reference more than a true copy. Minor differences include differences in inactive components. Biosimilars are identical in terms of safety, purity, and potency. For example, the differences could be related to variances in the actual production process, ingredient sources, and extraction processes. A biosimilar has a similar clinical outcome to a biologic, but is not a patented IP in itself.

Biologics, which have become popular thanks to innovation, are different than pharmaceuticals. They are complex molecules and held to much higher regulatory standards than chemical-based drugs. Biosimilars must meet an even higher threshold to be accepted as a similar. Thomas Felix, Medical Director of Global Regulatory Affairs and Safety at Amgen mentions that the vast majority of available biosimilars are not expected to be deemed interchangeable by the FDA.

The World Health Organization (WHO) worries that a naming convention would interfere with international efforts to harmonize drug names and biologic identifiers. The names created by USAN are typically the names used by the International Nonproprietary Name (INN) arm of WHO. A proprietary name would conflict with harmonization of nomenclature. Industry experts contend that assigning different suffixes might suggest to a prescriber that the drugs are dissimilar.

Like Felix, experts worry that the naming guidance would deeply impact the developing biologics market. Biosimilars help decrease prices for biologics through competition. A naming convention is unnecessary because there are currently identifiers used to track pharmaceuticals and Biologics throughout the supply chain, such as the National Drug Code (NDC).

The FDA sees the ruling as more of a bureaucratic and coding issue. Drug Code numbers are not typically recorded in patient records or billing practices, which makes adverse event tracking difficult for biologics and biosimilars with the same proper name. An NDC number is predominantly used by pharmacies when dispensing treatment, but biologics and biosimilars are typically given to the patient directly by the treating doctor. In that case, the pharmacy is bypassed and the NDC number would not come into play, thus requiring another tracking method for adverse event reporting.

The FDA is in a difficult position. The FDA has a purpose of promoting safety while improving patient access. The advent of biosimilars has made it possible for therapies and treatments to make their way to patients while decreasing expenses. Doctors want products that are safe for their patients and a naming convention would provide transparency. The use of suffixes simplifies an already complex supply chain and for the purposes of traceability, another tracking form is needed and that form must be standard with international nomenclature.

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