By Juan Serrano --
The Mexican General Health Law was reformed on June 11, 2009 to include an article 222 bis, which defined biotechnological drugs, and allowed for the approval of "biocomparables." The decree came into force on September 8, 2009, and the Ministry of Health had a 180-day period to issue all specific regulations pertaining to the approval of these biocomparables.
Even though the 180-day period expired on March 8, 2010, work on the project of regulations has continued, with input being provided by both the Mexican Association of Pharmaceutical Research (AMIIF) and the National Association of Drug Manufacturers (ANAFAM).
This past week, COFEPRIS (the Mexican regulatory authority) made the project of regulations available to the public, through the official website of the Federal Commission for Regulatory Improvement (COFEMER).
At this point, a period of 30 working days has been given to any interested party that wishes to provide comments to this project through COFEMER's website, after which the project can be either published or further analyzed.
The main items in this project are:
• A definition of comparability tests between an innovator and a biocomparable drug.
• An indication that biocomparable drugs will use the same name for the active ingredient as the innovator.
• The Health law regulations currently contain a 3-year period Roche-Bolar-like research exemption (related to the possibility of submitting an application for a marketing authorization before patent expiration, with intent to launch after the date of expiry). This 3-year period is eliminated, and the submission can now be made at any time. The modification in the corresponding article will also be applicable to chemical drugs.
• The timelines that COFEPRIS will have for approval of both innovator and biocomparable drugs are established.
A copy of this document can be found here.
Juan Serrano is an attorney with Olivares & Cia in Mexico City and frequent contributor to Patent Docs. He can be contacted at [email protected].
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