As biologics, biosimilars, and biomimics continue to emerge in Latin American countries, there remain regulatory inconsistencies on how these products should be tested and tendered in the management of rheumatic diseases. This prompted the Pan American League of Associations for Rheumatology (PANLAR) to develop a consensus statement on the matter, which was discussed in a review published in Clinical Rheumatology.
The PANLAR consensus comprised eight important positions, which include:
1) Biosimilars should be considered a viable treatment for patients with rheumatic diseases.
2) In an effort to assess potential safety issues, post-marketing pharmacovigilance programs should be implemented.
3) All regulatory agencies should establish a risk management plan (RMP) for biosimilars that mirrors the RMP for its reference products.
4) To allay safety concerns, the implementation of registries is encouraged to supplement post-approval surveillance of biosimilars.
5) A concise naming convention is required to accurately identify and discern a biosimilar from its reference.
6) There should be strategies in place that ensure the traceability of biosimilars and follow a stepwise approach in the supply chain, enabling the association of adverse effects with a specific medication.
7) Biosimilars should be priced considerably lower.
8) Biomimics are not recommended for use.
Regarding the PANLAR’s last statement on biomimics, the author especially concurred, and wrote that while “potentially useful, (biomimics) have not been developed to the same internationally rigorous and regulated standards as biosimilars. It will be interesting to see how this is received in those Latin American countries where biomimics are manufactured.”
The review’s author also discussed the more controversial areas of focus, such as the concerns associated with switching from a biologic to a biosimilar and automatic substitution of a biologic, a topic that often divides rheumatologists from not only payers and patients, but from each other in many cases. The author wrote, “most rheumatologists feel that the choice of drug is best made by the physician in partnership with their patient but, for high cost drugs, this responsibility may be taken over by the health care system/payer, or, potentially for financial reasons, the pharmacist.”
Overall, the author applauded the actions of the PANLAR, and said that they have “worked together productively to produce this useful consensus on important drugs, which will be instrumental in enhancing care for people with rheumatic diseases in the Americas.”