Availability of Biosimilar Pathways and Data/Marketing Exclusivity Globally
This is a follow-up to our post of September 27, 2013 in which we reviewed the availability of biosimilar pathways and data and/or marketing exclusivity for innovator biologics in Asia, Latin America and Eastern European countries.
During the last several months, we at the BRIC Wall expanded our research to gain a broader understanding of which countries provide biosimilar pathways and data and/or marketing exclusivity for innovator biologics. The results of our efforts are shown in the below table. Presently, over 40 countries have biosimilar pathways.
If any of our readers have information for any countries not included in the table and are willing to share that information, they are invited to contact the BRIC Wall with that information.
Click to view Table
- There does not appear to be any specific requirements for biosimilars in the Brunei “Guide to Application for Registration of Medicinal Products” (Guide). However, the Guide provides that medicinal products already registered in any benchmark regulatory country (such as Australia, Canada, Europe (Central), Malaysia, Singapore, Great Britain and U.S.) will facilitate the registration procedure of the biosimilar in Brunei.
- The rule in Canada is six years of data protection plus two years of market exclusivity (there is also a potential for an additional six months of pediatric extension).
- There are no statutory provisions dealing specifically with data exclusivity as it relates to biologics; however, Egypt applies the same rules and regulations on data exclusivity as required under the TRIPS regulations.
- Countries included are: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden.
- In Europe, eight years of data exclusivity and up to two years of market exclusivity are available. An additional 1 year of exclusivity is available for a new indication.
- Indonesia 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”.
- According to a February 5, 2014 article in the Tehran Times, Iran has developed its first “biogeneric” drug, Pegajen (a biogeneric of pegfilgrastim) for cancer patients. However, Iran is currently not a member of the World Trade Organization. Thus, drug companies in Iran have not had access to the same manufacturing facilities and process as those used to produce originator drugs, thus Iranian companies are unable to claim similarity between their versions and originator products. Additionally, it is believed that biogeneric approval in Iran might not have been authorized following as strict a regulatory process as that required for approval of biosimilars in Europe.
- Israel provides data exclusivity (non-reliance) protection (which is in fact only a limited marketing exclusivity); however, the Israeli provisions only apply to “chemical” drugs containing new chemical entities and do not cover biological drugs. Specifically, the data exclusivity (“DE”) provisions provide that the Ministry of Health (MoH) will not grant a marketing permit during the DE period. The DE period for drugs registered in Israel as of August 7, 2011 is six years from the date of receipt of marketing authorization in Israel or six and one-half years from the date of receipt of the earliest MA in any recognized country (namely, the U.S., Europe, Canada, Australia, New Zealand, Switzerland, Norway, Iceland or Japan). The DE period for drugs registered in Israel prior to August 7, 2011 is five years or five and one-half years respectively. As to data protection (non-disclosure), the position of the MoH is that an originator’s data are kept confidential indefinitely and regardless of DE.
- Jordan provides five years of data exclusivity for pharmaceuticals; however, it is unclear if it applies to biological products.
- An importer in Macau will be issued a license to import a biosimilar that has been registered and for which a Certificate of Registration has issued in a country outside of Macau, such as China, Singapore and Australia. If the biosimilar has not been successfully registered in one of these countries, the license will not be issued.
- Malaysia 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 5 years for a new drug product containing new a 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 3 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).
- There are no statutory provisions dealing specifically with data exclusivity as it relates to biologics; however, Morocco applies the same rules and regulations on data exclusivity as required under the TRIPS regulations.
- There is no specific legislation in Nigeria providing data exclusivity; however, Section 3 of the Food, Drugs and Regulated Products Act prohibits the disclosure of information supplied to the Food and Drug Administration and Control (NAFDAC) to assist the agency in reaching a decision on a subsequently filed application. For more information, see our previous post on “Regulatory Pathway for Biosimilar Products in Nigeria”.
- There are no statutory provisions in either Panamanian patent law or in the medicines regulatory laws dealing specifically with data exclusivity. However, there are provisions in the Industrial Property legislation and other privacy rules which deal with the protection of confidential (such as trade secret) information.
- There are no statutory provisions in South African patent law or medicines regulatory laws dealing specifically with data exclusivity. There are, however, provisions in the medicines regulatory law, and other legislation, which deal with the protection of confidential (such as trade secret) information.
- There are no statutory provisions dealing specifically with data exclusivity as it relates to biologics; however, Tunisia applies the same rules and regulations on data exclusivity as required under the TRPS regulations.
- In 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”.
- Marketing authorization (MA) for a generic drug containing the same active pharmaceutical ingredient as the original (innovator) drug is permitted not earlier than within five years from the date of receipt of the first MA for the original (innovator) drug. The five year data exclusivity (DE) period applies only with respect to those original (innovator) drugs for which MA application was submitted not later than two years from the date of the earliest MA grant date in any country. The DE rule is not applied in the following instances:
- (a) If a generic applicant secures the right to refer/use registration data of the original (innovator) drug in a way precluded by the current Ukrainian legislation; or
- (b) If a generic applicant submits its own full registration dossier that meets the requirements of the original (innovator) drug.
- The DE period may be extended for an additional one year (namely, up to six years) provided that within three years after obtaining the first MA for the original (innovator) drug, a new “superior” indication over the existing indication(s) is approved by the Health Authority (HA). It is the responsibility of the HA to adopt the rules and criteria for establishing whether a new indication is superior over an etg indication(s).
- There are no statutory provisions dealing specifically with data exclusivity as it relates to biologics; however, Uruguay applies the same rules and regulations on data exclusivity as required under the TRIPS regulations.
- Vietnam 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 5 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.
- Yemen does not have any specific regulations that provide for data exclusivity. However, the protection of data relating to a drug is automatically provided by the Government provided that it is not disclosed by the owner or competent authorities.
This post was written by Lisa Mueller. In addition, the BRIC Wall would like to thank the below firms that provided the information included in the table provided in this post.
Australia and New Zealand: Spruson & Ferguson
Argentina, Chile, Columbia, Ecuador, Peru and Venezuela: Clarke, Modet & Co.
Bahrain, Iran, Iraq, Afghanistan, Syria, Saudi Arabia, Yemen, Oman, Lebanon, Jordan, Kuwait, Qatar, United Arab Emirates: AGIP and the local AGIP offices in each of these countries
Brazil: Dannemann Siemsen
Bolivia: DAK Intellectual Property
Cuba: Aldecoa & Elias SRL
Europe: Modiano & Partners
Guatemela, Iran, Nicaragua, Peru: Ungria Patentees Y Marcas, S.A.
India: Chadha & Chadha
Indonesia, Macau, Malaysia, Mongolia, Philippines, Singapore, Thailand, Vietnam, Myanmar, Laos, New Guinea, Cambodia, Brunei: Spruson & Ferguson Asia
Israel: Dr. Shlomo Cohen & Co
Japan: Kawaguti & Partners
Mexico: Olivares & CIA, S.C
Nigeria: Nigerian Intellectual Property Law Watch
Pakistan: PakPat World Intellectual Property Protection Services
Republic of Korea: Central Intellectual Property & Law
Russia, Armenia, Azerbaijan, Belarus, Estonia, Georgia, Latvia, Kyrgyzstan, Kazakhstan, Lithuania, Tajikistan, Ukraine, Uzbekistan, Turkmenistan: Gowlings (Moscow)
South Africa, Algeria, Libya, Morocco, Tunisia, Mauritania and Egypt: Adams & Adams
Switzerland: CMS von Erlach Poncet AG
Taiwan: Lee & Li
Turkey: Deris Patents & Trademarks Agency A.S.