Regulatory News Roundup

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The following are some noteworthy news stories on the regulatory front:

  • The FDA shared best practices for biosimilar development.

  • The EMA okayed a combination of insulin glargine and lixisenatide for treatment of type-2 diabetes. If approved, which is usually a formality within around 60 days, the EU will be the first major market for this product.  The product was known as Lixilan during trials and will be marketed as Suliqua.
  • The FDA announced amendments to the citizen petition process, including for biosimilars applications, that will take effect on January 9, 2017. RAPS has some quick analysis on the rule changes.

Big Molecule Watch will continue to cover the latest regulatory developments, so check back for updates.

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