Biologics have become a big business. In fact, it is predicted that in twenty years, biologics will replace 70% of the global chemical (small molecule) drugs. Moreover, the global biosimilar market is expected to reach $3.7 billion dollars by 2015. The emerging markets of Asia, Latin America and Eastern Europe are particularly attractive for this growth. Some of the reasons is that these countries: (1) have a growing middle class; (2) are increasing their expenditures on healthcare; and (3) have a generic driven pharmaceutical markets.

In view of these tremendous market opportunities, we at the BRIC Wall thought it would be helpful to examine the availability of biosimilar pathways and data exclusivity for reference (innovator) biological products in several Asian, Latin American and Eastern European countries. The results of our efforts are shown in the below table.

¹Malaysia has guidelines on data exclusivity; however, these guidelines are not specifically directed to a reference biological product for biosimilars. However, we believe that the definition of “a new drug product containing a new chemical entity” for which data exclusivity is available would cover any such reference biological product provided that the product meets the requirements. “A new drug product containing a new chemical entity” refers to a product that contains an active moiety that has not been registered in accordance with the provisions of the Control of Drugs and Cosmetics Regulations 1984. An “active moiety” is defined as a “molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds) or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance.” The duration of data exclusivity is (1) up to five years for a new drug product containing a new chemical entity {which is calculated from the date the product is first registered or granted marketing authorization AND granted data exclusivity/test data protection in the country of origin or in any country recognized and deemed appropriate by the Director of the Drug Control Authority (“Director”)}; or (2) up to three years for a second indication (which is calculated from the date the second indication is first approved AND granted data exclusivity/test data protection in the country of origin or in any country recognized and deemed appropriate by the Director).

²Vietnam has provisions for data exclusivity generally; however, it does not make specific reference to a reference biological product used in comparability studies with a biosimilar product. The Ministry of Health (MoH) issued a circular dated March 1, 2010 providing guidelines for data exclusivity in Vietnam. The data exclusivity provisions apply to the registration of finished drugs that contain a new active ingredient. Because the definition of “drugs” includes biological medical products, we believe that this definition would also include reference biological products. The MoH is required to keep the data confidential for a period of five years from the date on which a pharmaceutical company is granted a license for marketing approval. The duration is shorter in those cases where the exclusive data does not meet the requirements for trade secret protection.

³Indonesia does not have any specific regulations that provide for data exclusivity. However, the protection of data and experiments relating to a drug is automatically provided by the Government (namely, the Ministry of Health) once a drug is registered. Specifically, Article 14(3) of Health Ministry Regulation of R.I. no. 10101 MENKES/PER/XI/2008 provides that a “registration document is a confidential document which can only be used for evaluation by the relevant officer.”

⁴In many countries, the periods of patent exclusivity and regulatory data exclusivity are completely independent and separate from each another. However, in Turkey, this is not the case. In Turkey, the period of data exclusivity is tied to the term of any issued Turkish patent having claims that encompass the active substance of the biological reference product. Specifically, the data exclusivity period for a biological reference product is six years from the date of first registration of the product in the European Customs Union {which comprises the member states of the European Union (such as Great Britain, Germany, France, Italy, etc.) as well as some other non-European Union countries (such as Turkey)}. However, this six year data exclusivity period is limited to the term of any issued Turkish patent having claims that encompass the active substance of the biological reference product. For more information, see our previous post on “Understanding Biologics and Biosimilars in Turkey”.

The BRIC Wall would like to thank the below firms that provided the information that is included in the above table.

Argentina, Chile, Columbia, Ecuador, Peru and Venezuela: Clarke, Modet & Co.

Brazil: Dannemann Siemsen

India: Chadha & Chadha

Indonesia, Malaysia, Philippines, Singapore, Thailand, Vietnam: Spruson & Ferguson

Mexico: Olivares & CIA, S.C

Turkey: Deris Patents & Trademarks Agency A.S.

Republic of Korea: Central Intellectual Property & Law

Russia: Gowlings

Taiwan: Lee & Li