- All > Medicine Information and Evidence for Policy > Medicines Policy
- All > Quality and Safety: Medicines > Quality Assurance
- All > Quality and Safety: Medicines > Regulatory Support
- Keywords > biopharmaceutical market
- Keywords > biopharmaceuticals
- Keywords > biopharmaceuticals - clinical comparability/similarity
- Keywords > biosimilar products - originator products
- Keywords > biosimilarity - biosimilars
- Keywords > marketing authorization - biosimilars
- Keywords > pharmacokinetic and pharmacodynamic equivalence - originator and locally manufactured biopharmaceuticals
- Keywords > registration - biosimilars
- Keywords > regulation of biosimilars
(2012; 4 pages)
Biopharmaceuticals mostly have a high unit cost and often prescribed for chronic medical conditions with possibility of long-term use. Therefore, they will impose a burden on either national health care systems or patients’ out of pocket. It is estimated that the average daily treatment of a patient with branded biopharmaceuticals will cost at least 22 times of those for small molecule medicines. Biopharmaceuticals are medicines produced from living organisms via genetic manipulation...
Biopharmaceuticals are large and complex molecules which their active substances are mostly polypeptides, glycoproteins, proteins, and nucleic acids. Therefore, it is practically impossible to manufacture an "identical" copy for these molecules...
Despite complexity of their molecules, biopharmaceuticals are very well characterized both for their clinical use and production methods. Biopharmaceuticals are also very sensitive to their production procedures.
When the manufacturing process is modified by scaling up or transferring it to alternative facilities, new products might show modified specifications. Even though these manufacturing changes are tightly regulated most of the time they still will cause observable changes in the final product. However, all of these products will be marketed under one single brand name indicating that regulators consider these changes in the range of "highly similar" products. The fact that their administration provides expected clinical outcomes also confirm their comparability. "Biosimilars" are biopharmaceuticals which are manufactured by non originator pharmaceutical companies following expiration of patent period. According to current guidelines and regulations for granting marketing authorization "similarity" should be proven between biosimilar and its corresponding originator biopharmaceutical...
Although biosimilars proved to be a cost effective intervention for providing effective treatment for patients, regulatory approaches proposed for marketing of these medicines by organizations such as EMA, FDA or even WHO may not suite needs of Iran market. Iran authorities should keep in mind that WHO biosimilar guideline is mainly adapted from EMA guideline and there is no proof that this guideline is in fact in line with the needs and interests of national pharmaceutical markets in low resourced countries such as Iran. Iran national pharmacovigilance center proved to be an efficient center. Therefore in order to make a balance between regulation of biopharmaceuticals manufactured by local industry and affordability of these medicines, Iran NRA should use this capacity as a tool in regulation of locally manufactured biopharmaceuticals. Author believes that Iran NRA should accept pharmacokinetic and pharmacodynamic equivalence between the originator and locally manufactured biopharmaceuticals as a measure of clinical comparability.