Data Exclusivity for Biologics

Data exclusivity for biologics provides protection to the clinical data of biological product. The innovator company submits the clinical data to the FDA, and the agency ensures that the protection restricts competitors-generic companies- from gaining access to the clinical data; hence avoiding generic companies' attempt to manufacture similar product (biosimilar) and gain profit from its commercialization.
Manufacturer of a biological company invest a lot of time and money in bringing a biological product from its development stage to its commercialization. For instance, on an average, it takes a decade long, and an expense of hundred million dollars for a company in bringing a new biologic to the market. Thus, an appropriate data-exclusivity period will help the manufacturer to reimburse the cost in bringing the product into the market.
Data-exclusivity period motivates research in developing new drugs. If data-exclusivity is ineffective, companies will focus on producing biosimilars, because of the readily available clinical data, and it is less likely that a company will attempt to put an effort in bringing a new drug into the market. If data-exclusivity is effective, the manufacturer tend to keep the cost of biologics relatively high so as to compensate the cost occurred in the drug development. A data-exclusivity encourages research in the healthcare industry; however, it is equally important for an appropriate period of restricting the data to the public. For example, data-exclusivity of 10 years keeps the biologics out of reach for the patients, and lesser period of data-exclusivity hinders drug discovery.
As every innovator companies brings it product to the market at a price that is expensive to the patients; patients would have less access to the biological product. Hence, an effective data protection for biologics is necessary that will support both research and affordability of medicines to the patients.
In US, a data-exclusivity of 5 years and a cost-sharing system will help achieve, both, affordability of drugs and research in biologics. In a cost sharing approach, the generic company who have access to the clinical data, shares the expenses incurred to the innovator company. A cost sharing approach will help the innovator company to reimburse its expense suffered during the developmental process. A short exclusivity period of 5 years will bring biosimilars early in the market; this will create a competition into the market, ultimately resulting to less expensive medicines, hence more accessible to the patients.
Such an approach will bring an advancement in the research of biological product that can be safe and effective in life-threatening diseases like cancer and HIV.

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