John F. Kouten

With government and economic pressures, combined with staggering year-over-year growth, biosimilars are no longer a dot in the rear view mirror; they are approaching fast. Experts say it is only a matter of time before an approval pathway makes biosimilars a reality. Senator Orrin Hatch (R-UT) describes biologics as "the future of medicine," and asserts that the Biologics Price Competition and Innovation Act of 2007 (BPCIA), a Senate bill that would allow for biosimilars, "ensures that we will continue to lead the world in biotechnology."

Communicating to key audiences about biosimilars with a sound, consistent message is crucial for corporate marketing and public relations professionals. Through strategic planning, support from your internal and external experts, and careful execution, professional communicators will be prepared to position their biotechnology and pharmaceutical companies for inevitable changes.

With public attention increasingly focused on healthcare costs, there has been a shift in the political climate toward reducing costs by making medications—including biologic medications—more accessible. Three bills have been introduced in Congress that would pave the way for biosimilars. Consider:

» The BPCIA, introduced by Sen. Edward Kennedy (D-MA) would grant branded biologic products 12 years of market exclusivity before generics production, and allow for some degree of substitution of branded biologics and require fewer pre-approval clinical trials than for innovator compounds.

» In the House, the Pathway for Biosimilars Act would allow for 12 years' exclusivity, and would add a two-year extension in case of a newly approved use for a biologic product. This bill, sponsored by Reps. Anna Eshoo (D-CA) and Joe Barton (R-TX), would add six more months to exclusivity if the Department of Health and Human Services (DHHS) requests pediatric studies. This bill was reintroduced to Congress on March 13, 2009.

» The third bill, the Access to Life-Saving Medicine Act of 2007, would establish an abbreviated approval process for biosimilars by not requiring duplication of certain clinical trials (as is required for generic small molecule drugs) to assess the degree of "comparability" between a biosimilar and its reference product. Introduced by Rep. Henry Waxman (D-CA), this bill would provide no exclusivity for brand-name products.

Much of the debate over biosimilars centers on the FDA's commitment to ensuring the efficacy and safety of these drugs. Drug companies must have effective, comprehensive issues management/communications programs to defend against generics manufacturers' claims of "sameness." Such programs should emphasize that evaluation of biosimilars must take into account not only the complexity of biologic products, but also the changes in manufacturing processes that would presumably be established for biosimilars.

Biosimilars on Pharma's Radar

The reintroduction of The Pathway for Biosimilars Act has generated additional buzz around this issue. President Barack Obama has pledged support for legislation governing biosimilars, but has advocated for shorter exclusivity periods than pharmaceutical companies are seeking.

In a March 17 white paper entitled, "Achieving the Right Balance between Innovation and Competition: The Role of Data Exclusivity," Johnson & Johnson supports a 12- to 14-year window of data exclusivity for patented biologics to prevent biosimilar companies from "working around" innovator companies' biologics patents. J&J argues that this data exclusivity will maintain incentives for continued investment in biotechnology by innovator companies.

Through Web site content, Genentech emphasizes that because of their complexity, biologic products can only be made similar, not identical. The company believes that indications for biosimilars should be established through clinical trials, and that biosimilars should only be substituted for innovator biologics if a comparative clinical trial demonstrates that the substitution is appropriate.

On March 19, Eli Lilly publicly announced its support for The Pathways for Biosimilars Act, noting that the Act would create a pathway that carefully weighs the needs of patients and stakeholder companies. This balance, Lilly says, would assure patients and payers the benefits that come from greater competition, would preserve incentives for biotechnology innovation, and would foster investments that will produce high-paying jobs in the life sciences.

In response to the reintroduction of the Pathway to Biosimilars Act, the Biotechnology Industry Organization (BIO), which represents more than 1,200 companies and academic institutions, issued a statement saying that the Act balances "the need to increase access, lower cost, ensure drug safety, and promote continued biomedical breakthroughs," while identifying differences between biologics and small molecule drugs. Similarly, the Pharmaceutical Research and Manufacturers of America (PhRMA) issued a press release announcing its support of the Pathway to Biosimilars Act while requesting that Congress require clinical trials to demonstrate equivalent safety and efficacy to the reference product.