Countering Generic and Biosimilar Threats (PH136)
Near-Term and Long-Term Strategies
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- Published 2010
- 246 Pages
- 500+ Metrics
- 130+ Charts and Diagrams
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Prepare for pharmaceutical generics and biosimilar competition and protect brand revenues
The next few years will bring an unprecedented number of patent expirations to the pharmaceutical industry. To retain market share in the battle against biosimilar and pharmaceutical generics, brands must devise a well-rounded strategy. But knowing which moves to make — and when — is no easy task, and decisions on how much to invest in a counter-generics strategy can make or break a brand's fortunes.
Countering Generic and Biosimilar Threats is your go-to resource for prioritizing and fine-tuning your counter-generics strategy. No other resource delivers this much information — combining benchmarks and industry insights — with such depth. Pore over analysis of 12 pharmaceutical counter-generics tactics; comb through recent case studies to see how other brand teams have implemented these tactics; and peruse brand profiles to understand, at a glance, how other teams have mapped out their strategies.
With this information you can:
- Design a multifaceted, diverse pharmaceutical generics and biosimilar defense strategy
- Use counter-generics task forces to drive strategy forward while building institutional knowledge
- Implement tried and true tactics that have proven successful in the months or years leading to patent expiration
- Quickly implement strategies that are low-cost, but high-impact
- Retain market share in the face of biosimilar and generic competition
- Learn the differences and similarities between biosimilar and counter-generics tactics
CEI's research finds that over 40% of teams wait to start until four years before patent expiry to begin preparing for biosimilar and pharmaceutical generics. While developing this study, we specifically aimed to address misperceptions and problems that are obstacles to effective planning, including the challenges posed by limited time and budgets. Pharmaceutical Generics defense is crucial for a branded drug at any point in its lifecycle — it's never too early or too late to think about this critical challenge.
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Companies Included in Biosimilar and Counter-Generics Research
- Alcon Labs
- Amphastar Pharmaceuticals
- AstraZeneca
- Baxter
- Biogen Idec
- Biovitrum
- Boehringer Ingelheim
- Chiesi Farmaceutici
- Claris Lifesciences
- Cubist Pharmaceuticals
- Eli Lilly
- Genentech
- Genzyme
- Gilead Sciences
- Hospira
- Labopharm
- MedImmune
- Midas Pharma
- Merck
- Novartis
- Novo Nordisk
- Nycomed
- OSI Pharmaceuticals
- Pfizer
- PregLem
- Roche
- Shire
- UCB
- Several brand consultants and marketing agencies also contributed to this research.
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Biosimilar and Counter- Generics Metrics
Pharmaceutical generics task force data:
- Number of companies with a dedicated task force
- Task force leadership, structure and staffing FTEs
- Functions represented on the task force
- Task force timelines in counter-generics planning
- Functions involved in counter-generics planning for companies that do not form task forces
Breakdown of individual strategies (includes timing, investment and ROI/results):
- Marketing and exclusivity extensions
- Defensive pricing and price changes
- Counter-promotion
- Litigation
- Citizen petitions
- Pediatric exclusivity
- Lifecycle management and line extensions
- New formulations
- Next-generation products
- New indications
- Combination products
- Market crossover tactics
- Authorized generics
- Generics subsidiary
- Rx-to-OTC switches
Biologics and biosimilars
- Year and country of expected biosimilar competition for surveyed biologic brands
- Anticipated revenue loss to biosimilar competition
- Therapeutic areas for surveyed biologic brands
- Threat posed to biologic brands from changes in US biosimilars legislation
- Biologics' counter-generics strategies
Company and brand counter-generics profiles
- Basic company information (size, markets)
- Functions leading and participating in counter-generics effort
- Counter-generics staffing FTEs contributed by different functions
- Counter-generics timeline relative to patient expiration
- Specific strategies and tactics used across company's brands
- Brand-specific profile:
- Annual sales before and after generics (where available)
- Year of patent expiry
- Brand's markets by region
- Number of generics anticipated and currently competing
- Tactics and investments:
- Point at which planning began for specific tactics
- Time required to execute each tactic
- Investment (where available)
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Biosimilar and Counter-Generics Report Sample
The following excerpt is taken from Chapter 1, "Decision-Making Groups and Counter-Generics Strategies." The full report explores which functions comprise counter-generics task forces and when these groups are created. Metrics on timing, FTE count and task force make up are divided into four company sizes.
Task Force Leadership
As discussed in the previous sections, many teams make up counter-generics task forces. This leads to a variety of these teams taking the leadership role. Figure 1.6 [seen in full report] shows the teams who head up pharmaceutical generics and counter-generics task forces. The graphic also provides some depth by breaking responses down by company size.
As seen, 35% of companies place brand management in charge of their task forces. This is not surprising, as brand managers are the most familiar with the market for their products. However, in cases in which a task force handles more than one product or therapeutic area, assigning brand management to the leadership role may no longer make the most sense.
Lifecycle management and legal teams are the second most common groups to head up pharmaceutical generics task forces. Twelve percent of surveyed companies employ lifecycle management in their leadership positions. Certainly, lifecycle management teams bring the ability to work across numerous products, as well as the expertise of managing products at every stage of their lives. Placing this group in charge also allows for the continued growth of the group as the team will not dissolve in the way a brand team might once a product goes generic. In other words, the lifecycle management team will use the information gathered in one generic defense to use in the next occurrence and so on.
This following sample is excerpted from Chapter 2: "Marketing and Exclusivity Tactics: A Short-Term Solution." The full chapter contains timing, investment and ROI/results data for five tactics, including defensive pricing.
Defensive pricing is a widespread undertaking — 57% of companies employed some form of pricing defense in the years 2008 to 2010, as shown in Figure 1.23. Similarly, 49% plan to use defensive pricing between 2011 and 2013 (seen in Figure 1.29). The cost of this counter-generics option may help to explain its frequent use; in most cases, it is not expensive.
For brand teams, defensive pricing provides the flexibility of immediate implementation. That is, teams who choose to employ a defensive pricing plan can expect to apply that plan within weeks. Figure 2.2 shows that 77% of responding companies begin planning a defensive pricing strategy within two years before patent expiration. The other 23% begin planning between two and four years prior to patent expiration.
Planning can begin so late in the product's lifecycle because a defensive pricing strategy can be implemented quickly. As shown in Figure 2.3, defensive pricing plans require an average of only 10.9 months to execute — Company 29 and Company 9 needed as little as three and four months, respectively, for pricing changes to come to fruition. This expediency, coupled with the imminent appearance of generic competitors, spurs brand teams to facilitate pricing strategies at the tail end of a product's patent life.
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