E-DRUG: Biosimilar Compounds
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Dear All,
There is no question that biopharmaceutical compounds obtaining increasing
role in countries health sector. Despite the efficacy of these compounds in
improving patients condition, most of these medicines due to their high
cost are not affordable for health systems in developing countries.
However, the fact that some of these compounds are going off their patents created the hope that multi source production of these compounds (Biosimilars) might improve their affordability for patients in both developed and developing countries.
However, recent discussions, which sometimes fueled by biopharmaceutical
companies created considerable ambiguity for national regulatory authorities regarding registration of Biosimilar compounds.
Most of these debates explain that Biosimilar compounds are not the same and therefore any company which makes follow-on-biologic compounds should
provide full range of safety and efficacy data for registartion. If we
accept this I may ask the question that in such cases that Biosimilars are
not similar to originator compounds and regulatory authorities should not
treat them as generic compounds why originators should be protected by
patent laws?? Because they believe Biosimilars are not like generic
compounds and therefore they should not object marketing a Biosimilar as
breaching the patent Law.
I believe due to increasing importance of these compounds and concerns about their safety, efficacy and also availability in member states, WHO should get involve in developing guidelines for dealing with the issues surrounding registration of Biosimilar compounds. Developing such a guidelines by WHO will contribute to assured registration on these compounds and through that improving their availability and affordability.
A. Majid Cheraghali, Pharm.D.; Ph.D.
Food and Drug Dept.
Ministry of Health
Tehran 15311- Iran
Tel: (9821) 6467266
Fax: (9821) 6705868
m.cheraghali@bmsu.ac.ir