PERTH, Australia – Most multinational pharma companies vehemently opposed the Therapeutic Goods Administration's plan to stick with the status quo in Australia and use a single name for biologics and biosimilars without a specific identifier suffix. Even so, the regulator said it would continue to use its single naming system and beef up its adverse event reporting system.
Currently, biosimilars in Australia share an Australian Approved Name (ANN), which is usually the International Nonproprietary Name (INN) assigned to the reference product by the WHO INN Expert Group. In the absence of an INN, a name is agreed on by the sponsor and the TGA during the registration process.
The TGA said the move aligns with the European Union and the World Health Organization approaches and doesn't add unnecessary regulatory burden while at the same time avoiding the "complexity and potential confusion that would be associated with the introduction of a suffix-based system with retrospective coverage."
But stakeholders were quick to disagree with the TGA's stance and said that even retrospective coverage would be a better way to go.
"A system that includes the use of designated suffixes in ordering, prescribing, dispensing, recordkeeping and pharmacovigilance practices for biological products would provide a consistent, readily available and recognizable mechanism for patients and health care professionals, including clinicians and pharmacists, to correctly identify these products and also avoid errors in ordering, dispensing and recordkeeping," Medicines Australia said in its comments.
The association that represents innovative pharma companies operating in Australia urged the regulator to adopt an approach that was in line with the U.S. FDA practice of using a common core name and suffix identifier.
In line with national biosimilar uptake policy
The TGA decision to stick with the status quo aligns with Australia's biosimilar medicines uptake policy that aims to reduce costs to the national Pharmaceutical Benefits Scheme (PBS) by introducing more biosimilars. A biosimilar awareness initiative was launched in May 2015 to encourage health care providers to prescribe biosimilars when possible.
As part of that policy to encourage physicians to prescribe biosimilars, the regulator imposed a higher authority bar for a reference biologic to be prescribed; whereas the biosimilar product requires a lower, more streamlined authority.
All medicines in Australia are required to have the brand name of the medicine and the active ingredient on the main label as well as the dosage form, strength and Australian registration (AUST R) number. The contact details of the Australian sponsor are also required on the packaging.
When reporting adverse events, the product's trade name as well as non-proprietary name will need to be provided. No new labeling requirements will be imposed.
Although there is no global policy, there are three different international approaches to biosimilar naming conventions. Europe uses the INN, unmodified, supported by 2-D-barcoding requirements; the U.S. FDA requires a four-letter suffix added to the non-proprietary name of all biologics; and Japan's Pharmaceuticals and Medical Devices Agency requires a "BSn" biosimilar identifier.
In its consultation, the TGA offered four options that it asked pharma companies to choose from. Those options suggested:
1. retaining the status quo and using the approved biological name to identify the active ingredient in both the reference product and the biosimilar product. Unique identification would rely on the allocated Australian registration number (AUST R) and trade name;
2. retaining the status quo but including activities to increase public reporting of adverse events;
3. adopting a barcode system similar to the EU, which requires products to have a unique 2-D barcode that contains information including the product code, national identification number, batch number and expiration date;
4. introducing suffixes to the naming of biologics similar to the U.S. FDA approach. This option would make the biosimilar and reference products "appear as different drugs for prescribing purposes because they would be presented as distinct entries in prescribing lists and would therefore be displayed separately for the prescriber to choose from."
Concern over switching to biosimilars unfounded
Medicines Australia said that its members strongly believe that all biologics and biosimilars need to be distinguishable from each other, which would not be possible under the TGA's nomenclature plan.
"Medicines Australia believes that the status quo is untenable," and that existing "shortfalls in adverse event reporting, product misattribution and unreliable provision of either AUST R or proprietary names demonstrates the [widely] accepted need to adopt measures that will enhance patient safety and pharmacovigilance systems," the association said.
Biosimilars listed on Australia's PBS have been simple biosimilars and have been limited to a small number of products, the association said. But as more complex products come on the market, the TGA should reconsider its current policies and opt for the approach used in the U.S., Medicines Australia urged.
It pointed to a data analysis of adverse events (AEs) pulled from the TGA database for filgrastim, which showed that more than 36 percent of adverse event reports were "not able to be attributed to a specific product."
Conversely, in analyzing adverse events for epoetins, which have unique names, (epoetin alpha, epoetin beta, etc.) only 3 percent of AE reports were classified as "ambiguous." The association stressed that the use of distinct names allowed events to be tracked back to specific products, reducing the number of ambiguous reports.
With regard to adverse events, the TGA acknowledged that some stakeholders voiced concern that switching patients from a reference product to a biosimilar could trigger "immune-mediated reactions that have not been observed for the innovator medicine." However, the regulator said there has been little evidence to support that suggestion.
The agency said it might move toward adopting a barcode system similar to the EU requirements in the future. The decision to follow EU conventions is in line with Australia's policy to align its regulations with the EU wherever possible. Currently, Australia does not require bar codes on pharmaceutical labels.
Amgen Australia, which develops both innovative and biosimilar products, said in its comments it supported the option to align more closely with the U.S. approach, because using distinguishable suffixes would be more readily recognizable to health care professionals.
Improving pharmacovigilance alone would not be sufficient to track adverse events for biologics, Amgen said. It said that biosimilars "have the potential to be significantly more immunogenic than traditional small-molecule drugs," and using shared AANs in Australia (a practice used for generic drugs) are not appropriate for biologics.
Amgen said that a biosimilar could be licensed for fewer indications and routes of administration than a reference product and could also have different delivery systems, and those could cause potential medication errors. The company said prescribing and dispensing need to be more closely tracked.
It suggested that a globally unified policy where biologics have distinguishable identifiers would be beneficial for patients and ease the burden for manufacturers.
Abbvie Pty also strongly encouraged the TGA to adopt unique suffixes to better distinguish non-proprietary names for all biologics. It suggests using the INN, with a suffix identifier connected by a hyphen. It also supported a globally harmonized approach for the same reasons that Amgen stated.
Mylan Australia, as well as other biosimilar stakeholders, such as the International Generic and Biosimilar Medicines Association, were in favor of the current system because it would encourage the use of biosimilars uptake.