Current regulatory and scientific considerations for approving biosimilars in Iran.

With the expiration of patents on the first generation of rDNA biopharmaceuticals, competitors began to introduce biosimilar products. The concept of generics as applied to classical chemical drugs cannot be used for biotechnology products. Physicochemical characterization, bioassays and animal studies do not have the ability to predict reliably the safety and efficacy of biotherapeutics. Clinical studies are always necessary. While regulators all over the world were really in need of a comprehensive guideline in this area, WHO introduced a guideline which is principally a basis for regulating biosimilars and is applicable in Iran, as well as many other countries.

Comparison of the adjuvanticity of aluminum salts and their combination in hepatitis B recombinant protein vaccine in assessed mice.

BACKGROUND: Several adjuvants have been evaluated for vaccine formulations but aluminum salts will continue to be used for many years due to their safety, low cost and adjuvanticity with different antigens. Two commonly used aluminum adjuvants, aluminum hydroxide and aluminum phosphate have different adjuvanticity properties. Commercial recombinant protein hepatitis B vaccines containing aluminum hydroxide is facing low induction of immunity in some sections of the vaccinated population. OBJECTIVE: In this study, to follow the current global efforts in finding more potent hepatitis B vaccine formulations, adjuvanticity of aluminum phosphate, aluminum hydroxide and their combinations has been evaluated. METHODS: The formulated vaccines were administered intra-peritoneally (i.p.) to BALB/c mice and the titer of antibody was determined after 28 days using ELISA technique. The geometric mean of antibody titer (GMT, mIU/ml), seroconversion and seroprotection rates, ED50 (ng) and relative potency (microg/dose) of different formulations were determined. RESULTS: GMT of antibody titer, seroconversion and seroprotection rates showed significantly higher adjuvanticity for aluminum phosphate than other formulations. The ED50 of aluminum phosphate was approximately two fold less than other formulations. CONCLUSION: Aluminum phosphate showed more adjuvanticity than aluminum hydroxide and their combinations in hepatitis B protein vaccine. The use of aluminum phosphate as adjuvant leads to higher immunity which may result in more protective response in vaccinated groups.