The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Subsequent Entry Biologics (aka Biosimilars) get Final Health Canada Guidance, 6 Years of Data Exclusivity

Health Canada released the finalized version of its Guidance Document for “Subsequent Entry Biologics” (SEBs).  The final version is mostly the same as the draft guidance released last March, and actually comes after the approval of Canada’s first SEB last April.

SEBs are a class of drugs that the EU calls “biosimilars” and the U.S. calls “a class of biologics we may recognize one day if health reform passes”“follow-on biologics,” but the gist is that they are copycat versions of existing large-molecule drugs.  Because of their complexity, different versions of the same biologic cannot be characterized as identical.  Hence “similar”.

Regulators are seeking a balance with respect to how much biosimilars can rely on data from the original (“reference”) drug in applying for their own approval, and with respect to how long to protect the reference drug’s data.  Here are some highlights of Health Canada’s approach:

  • A full New Drug Submission required for SEBs, (not an abbreviated submission, as for small-moelcule generics).
  • The data exclusivity period — the time that must elapse before an SEB can use the data from the reference biologic’s application — is 6 years.
  • Studies comparing the reference biologic to the SEB must be conducted in a side-by-side format.

For more information, check out the Ogilvy Renault Pharma in Brief publication, or read the whole Guidance Document.

About these ads

2 responses to “Subsequent Entry Biologics (aka Biosimilars) get Final Health Canada Guidance, 6 Years of Data Exclusivity

  1. Ashritha (infoalcpl@gmail.com) October 9, 2010 at 3:04 am

    Biosimilars in India

    Though biosimilars are highly valued for their effectiveness as treatments, the costs-per-patient of many biologics are often significant and sometimes can be prohibitive. As all countries tussle with the issues of access to biologics and other medicines while confronting increasingly limited health care resources; achievement of the full potential of biosimilars is becoming increasingly challanging. My collegues and I recently authored, What we believe to be, one of the most indepth reports on the Biosimilars industry in India. If anyone is interested in this, feel free to write to me at infoalcpl@gmail.com. Ashritha.

  2. Pingback: Biotech Trends in 2011: Biosimilars « The Cross-Border Biotech Blog

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

Follow

Get every new post delivered to your Inbox.

Join 130 other followers