Manufacturing Issues Shape Follow-On Biologics Debate - Pharmaceutical Technology

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Manufacturing Issues Shape Follow-On Biologics Debate
Product characterization and production challenges are key issues in developing a pathway for biosimilar therapies.


Pharmaceutical Technology


Facing strong political pressure to legalize follow-ons, brands are seeking added patent protection from any new legislation. The Hatch–Waxman Act provides five years of exclusivity before generics can challenge a new drug's patent. In Europe, drugs and biologics essentially are protected for 11 years, which looks attractive to US innovators, especially small biotechnology companies. The high cost of developing new biologics—which the Tufts Center puts at $1.25 billion fully capitalized—and more expensive manufacturing processes warrant stronger protection from patent litigation, industry claims.

The lead biogeneric bill, which is sponsored by Rep. Henry Waxman (D-CA) and Sen. Hillary Clinton (D-NY), would make it possible to approve a follow-on with minimal clinical testing. Another House bill would require clinical trials and rule out therapeutic equivalence. Senate HELP Committee Chairman Edward Kennedy (D-MA) is working with other panel members on a compromise measure that addresses clinical-research and exclusivity issues with an eye to moving legislation forward this year.

Let FDA decide

Dealing with such a wide range of complex issues requires a flexible regulatory policy, said Woodcock. Like EU regulators, FDA envisions a case-by-case approach to testing and evaluating the comparability of follow-ons. One issue is to what extent follow-on sponsors can refer to innovator data in establishing abbreviated testing processes. BIO noted in its white paper that manufacturer information on product formula and production process is considered a trade secret, and that it is illegal for FDA to rely on such innovator information when evaluating follow-ons.

To assist manufacturers, FDA says it will develop its white paper into further guidance on what data it recommends for developing follow-ons of those biologics regulated as drugs under the FDCA such as human growth hormone and insulin. Additional guidances will address technical issues such as immunogenicity and physical characterization methods for follow-ons. Establishing an approval pathway for an initially limited group of biotechnology therapies would set the stage for expanding these approaches to a broader range of biotech therapies.

FDA evaluation of such products will be complex and time-consuming, but Woodcock said agency staffers have the expertise to make the hard decisions that will arise. Overall, agency officials anticipate a gradual evolution toward follow-ons. While FDA now has the tools to assess the comparability of small peptides, Woodcock explained, it may take a decade to develop similarly precise methods for evaluating larger molecules. In its white paper, FDA notes that it expects to be able to evaluate structural similarity for various products as analytical technology continues to improve.

Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634,


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