The International Psoriasis Council (IPC) recently suggested the need for guidelines to aid in the standardization of pre-clinical assessments to determine similarity of emerging biosimilars for the treatment of psoriasis in a report published in the British Journal of Dermatology (Feb. 2016; 174(2):282-286).
“Biosimilars are new to Canada and dermatologists have little experience with biosimilars for the treatment of psoriasis. Therefore, it is important for dermatologists to realize and remember that these [similar biologics] are not the same as the original biologics,” Dr. Ron Vender, associate clinical professor of medicine at McMaster University in Hamilton.
“In other specialties biosimilars have been used, but right now there are a lot of unknowns regarding the effects [of biosimilars] in dermatology,” he said.
Clinical trials ongoing
Dr. Vender added that “Biologics consist of large complex molecules that require a difficult manufacturing process. The biosimilar that is presently available has not been tested in patients who have psoriasis at the present time. However, there are ongoing clinical trials evaluating some of the newer biosimilars for the treatment of psoriasis, which should alleviate the safety concerns that we as dermatologists have.”
He cautioned, however, that these ongoing clinical trials assessing the use of biosimilars in psoriasis are short term trials that are not as extensive and involve fewer patients than what was expected when the original biologics were approved.
“Because fewer clinical studies will be performed, regulatory authorities and prescribing dermatologists need to rely upon pre-clinical analytical studies to define similarity between a biosimilar and an originator biologic,” the IPC authors wrote.
The IPC paper—‘Biosimilars for Psoriasis: Pre-Clinical Analytical Assessment to Determine Similarity’—is the first of a three part series scheduled to be released, said Dr. Vender. The creation of this series involved a collaboration of the Biosimilars Working Group by councillors of the IPC.
As a way of assuring high quality biosimilars in the future, Dr. Vender and his colleagues from the IPC recommended that companies involved in producing biosimilars follow a minimum set of analytical standards in the pre-clinical characterization of their compounds. These standards should include the following:
• Confirmation that amino acid sequence of the biosimilar is identical to the originator biologic;
• Analysis of post-translational modifications, such as glycosylation, acetylation, sulfation, phosphorylation, and glycation, which should be repeated regularly over time, especially with changes in manufacturing performance;
•Assessment of drug charge;
•Assessment of drug binding affinity to target; •Performance of relevant assays to determine biologic function;
•Analysis of excipients, impurities, and aggregates; and
•Testing for end-product drug stability and delivery device.
“The proposed strategy aims to enhance the sponsor’s ability to detect and track any potential difference in the pre-clinical data that may affect downstream decisions regarding in vivo and clinical studies,” the authors wrote.
According to the authors, meeting such standards may best assure the creation of safe, effective, and high quality biosimilar drugs for patients with psoriasis.
“At the moment the main fear about biosimilars is that there are a lot of unknowns because it is new to dermatology. We have to approach these new drugs with caution until we get further clinical information released,” Dr. Vender told THE CHRONICLE.
“We don’t know yet how things will play out. Biosimilars could be beneficial from a cost perspective or it could have negative impact on our patients if they have side effects and we do not know that they have been switched from a biologic to a biosimilar,” he said.
Dr. Vender said that a pharmacist can suggest a switch and a doctor can approve it, but the likelihood is that the payers may insist on a less expensive alternative to the biologic, and as a result the patient and doctor might not know whether they are given a biosimilar or the originator name-brand product.
“The second article in the series about biosimilars for the treatment of psoriasis is planning to address the clinical research required to determine similarity between original biologics and biosimlars,” he said.