On the Right Pathways

In recent years, more than $15 billion worth of branded biologic medications have lost patent protection. According to The New England Journal Medicine, the patents for an estimated 10 percent of biologic products are expected to expire each year for the next 10 years, leaving approximately 25 products open to generic competition by 2013, and 35 products by 2017. Consequently, numerous companies are working to bring generic versions of biologic products to market.

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.

The Buzz Surrounding Biosimilars

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.

Don't Wait, Communicate

In light of the strong industry response, innovator companies must establish strong, consistent, and frequent communications regarding biosimilars. Many biologics have already lost patent protection, and while the timing of the first biosimilar approval is unclear, it's never too early to communicate. Well-crafted, strategic messages will provide stakeholders with valuable information on biosimilars and bolster a company's leadership within the biopharmaceutical community.

Here are some key strategic communication activities to consider:

» Scenario planning and communications time lines Legislative, regulatory, and competitive environments should be carefully monitored, and strategic planning should account for all potential scenarios. Specific communications activities should be timed to coincide with developments in Congress, FDA, and the market.

» Internal communications networks and committees Form committees, in advance of legislative actions, that are empowered to disseminate timely, actionable communications within the organization. Companies should not overlook opportunities to share executives' role in driving policy with internal audiences.

» Professional communications Innovator companies' positions regarding biosimilars should be made clear to physicians, pharmacists, and other professionals with prescribing privileges to reinforce the scientific pedigree of biologic products.

» Third party coalition building Medical professional societies and trade groups are important allies in defending the primacy of biologics. Coalitions with these organizations should be nurtured and strengthened.

» Advocacy relations Consumer groups and patient advocacy organizations are also key allies to cultivate.

» Policy communications Government relations departments should be involved in efforts to communicate companies' positions on follow-on biologics to key policy constituencies.

» White papers Industry and company positions, supported by sound scientific evidence, can be compiled in white papers delivered to key audiences.

» Q&As Answers to anticipated questions from the media, medical professionals, consumers, and other key audiences should be developed for use by internal and external spokespeople.

» Media-trained spokespeople Communications professionals should facilitate formal media training for their company spokespeople to prepare for questioning from the media, investors, and other external audiences.

» Proactive media relations Relationships with journalists should be cultivated to create a receptive media environment for the company's position in advance of any legislative or market developments. The company should provide something of value, in the form or an executive interview or a video/tour of a biologic facility, in order to facilitate the relationship.

» Investor relations Support from the investor community can be vital to strengthening companies' positions on biosimilars and other key issues.

» Safety issues Company officials should prepare standby statements in advance of anticipated issues. For example, postmarketing studies of biosimilars may allow class safety issues to resurface. The media may cite the reference biologic in articles.

As the debate over biosimilars intensifies, innovator companies will need to be both savvy and aggressive in advancing their positions. The companies that are able to frame the debate in terms of a commitment to quality, safety, and sound science will be better positioned to compete in a market with biosimilars.

John F. Kouten is CEO of JFK Communications, a PR firm for biotechnology, pharma, and medical technology companies. He can be reached at jfkouten@jfkhealth.com