Counter-Generics and Biosimilar Defense Strategies (PH181)

Harnessing Competitive Tactics to Mitigate Post-Patent Revenue Erosion
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Published 2013
233 Pages
500+ Metrics
150+ Charts and Diagrams

Create Robust Counter-Generics Strategies to Maximize Market Share As Patents Expire

Fresh off of 2012’s patent cliff, the life sciences industry is bracing for a second cliff in 2015 — with sales losses that may total some $33.5 billion.  For any company looking toward the later stages of brand life, now is the time to plan a counter-generics strategy.

To prolong brand sales and mitigate revenue erosion, key initiatives — including exclusivity extensions, line extensions and competitive tactics — require ample time to yield lucrative results.

This report examines counter-generics and biosimilar strategies for Top 10, Top 50 and small pharmas.  Data show counter-generics strategy, team structures and staffing, and 39 new case studies explore companies’ experiences deploying 13 different counter-generics tactics.  At the deepest level of detail, profiles depict 10 counter-generics team structures, strategy mixes and planning timelines.


Top Reasons to Buy this Report

Plan for and implement a diverse and robust set of strategies: Compare your team’s action plan against the ideal timeline for counter-generics strategy development to learn when to use the right tactic at the right time.  Then combine strategies to maximize a brand’s revenue potential.

Build a strong counter-generics task force Determine whether generics defense efforts require a dedicated structure or an ad hoc team, and position key functions — including product and brand management and business development — to drive strategy planning.

Prepare for coming biosimilar competition and changing approval pathways The biologics landscape is changing as more biosimilar products seek approval.  Compare biosimilar pathways in the US and EU markets, and ready counter-biosimilar tactics to supplement the inherent barriers to developing and manufacturing biosimilar products.

Biosimilar and Counter-Generics Metrics

Chapter 1: Shaping an Effective Counter-Generics Strategy Through Team Structure and Generic Partnerships

Chapter Benefits

  • Maximize revenue potential by planning counter-generics strategies earlier in the product lifecycle.
  • Determine whether counter-generics strategy creation requires a dedicated structure or an ad hoc team.
  • Build dedicated counter-generics teams or non-dedicated task forces using the best-fit FTEs.
  • Decide each function’s involvement — whether FTEs are formally on teams versus contributing to them — plus the number of FTEs from each function.
  • Learn from other companies’ experiences partnering with generics manufacturers to further product revenue.

Key Metrics 

52 charts detail the prevalence of dedicated counter-generics teams, group structures, team staffing and number of generic manufacturer partnerships.

  • 2 real-world examples of dedicated counter-generics team structures
  • Number of years prior to patent expiry team begins developing counter-generics strategy (Top 10, Top 50 and small pharma)
  • Percentage of companies with dedicated counter-generics management structures (Top 10, Top 50 and small pharma)
  • Departments/functions represented on or contributing to dedicated counter-generics teams (Top 10, Top 50 and small pharma)
  • Department/function leading dedicated counter-generics teams (Top 10, Top 50 and small pharma)
  • Number of FTEs representing specific departments on dedicated counter-generics teams, by company
  • Departments/functions contributing to counter-generics strategies at companies with no dedicated team for all company types (Top 10, Top 50 and small pharma)
  • Percentage of companies that have partnered with a generics manufacturer (Top 10, Top 50 and small pharma)
  • Companies’ perception of experience with generics manufacturer partnerships for all companies and by company type (Top 10, Top 50 and small pharma)
  • Prevalence of party initiating generics licensing process (branded company, generics company or third party)


Chapter 2: Exclusivity Extension Tactics: Maximizing Patent Potential

Chapter Benefits

  • Implement exclusivity tactics to extend patent protection and maximize product revenue.
  • Weigh the benefits and risks of four (4) exclusivity extension tactics:
    • Litigation
    • Pediatric exclusivity
    • Citizen petitions
    • Pay for delay deals
  • Compare best-fit counter-generics tactics based on company type, planning time and available resources.
  • Explore 3 product case studies and 1 brand profile for each exclusivity extension tactic (with the exception of citizen petitions).

Key Metrics

14 charts detail the prevalence of exclusivity extension tactics within surveyed companies’ overall counter-generics strategies — as well as real-world brands’ experiences using these tactics.

  • Average percentage of exclusivity extension tactic usage for all companies
  • Percentage of all companies using specific exclusivity extension strategies:
    • Litigation
    • Citizen petition
    • Pediatric exclusivity
    • Pay for delay
  • Brand profile highlighting use of each exclusivity extension strategy (litigation, citizen petition, pediatric exclusivity and pay for delay)
  • Change in global sales beyond patent protection (historic sales and projected sales) for specific branded drugs:
    • Abilify
    • Cymbalta
  • Number of potential pay for delay settlements by fiscal year (2004­–2012)


Chapter 3: Competitive Tactics: Proven Strategies for Combating Generic Erosion

Chapter Benefits

  • Leverage competitive tactics to prepare for generic competition during late-stage planning efforts.
  • Drive brand loyalty and patient adherence through patient-facing pricing counter-promotion strategies.
  • Weigh the benefits and risks of four (4) competitive tactics:
    • Pricing
    • Authorized generics
    • Generics subsidiaries
    • Counter-promotion
  • Compare best-fit counter-generics tactics based on company type, planning time and available resources.
  • Explore three (3) product case studies and one (1) brand profile for each competitive tactic.

Key Metrics

19 charts show the prevalence of competitive extension tactics among both surveyed companies’ counter-generics strategies and real-world brand implementations.

  • Average percentage of competitive tactic usage for all companies
  • Percentage of all companies that use specific competitive strategies:
    • Pricing
    • Authorized generic
    • Generic subsidiary
    • Counter-promotion
  • Brand profile showing overview and counter-generics tactics for each exclusivity extension strategy (pricing, authorized generics, generic subsidiary, counter-promotion)
  • Change in global sales (historic sales and projected sales) beyond patent protection for specific branded drugs:
    • Lipitor
    • Fosamax
    • Lotrel
    • Zoloft
    • Geodon
    • Epivir


Chapter 4: Line Extension Tactics: Driving Revenue Growth through Clinical Development

Chapter Benefits

  • Plan early to implement line extension tactics that hold market share through brand loyalty, improved patient adherence and potential patent protection.
  • Weigh the benefits and risks of five (5) line extension tactics:
    • New formulations
    • New indications
    • Next-generation drugs
    • Combination drugs
    • Over-the-counter (OTC) switch
  • Compare best-fit counter-generics tactics based on company type, planning time and available resources.
  • Explore 3 product case studies and 1 brand profile for each line extension tactic.

Key Metrics

18 charts show the prevalence of line extension tactics within surveyed companies’ counter-generics strategies and real-world brands using these tactics.

  • Average percentage of line extension tactic usage for all companies
  • Percentage of all companies that use specific line extension strategies:
    • New formulations
    • New indications
    • Next-generation drugs
    • Combination drug
    • OTC switch
  • Brand profile showing overview and counter-generics tactics for each exclusivity extension strategy (new formulations, new indications, next-generation drugs, combination drugs and OTC)
  • Change in global sales (historic sales and projected sales) beyond patent protection for specific branded drugs:
    • Propecia and Proscar
    • Diovan


Chapter 5: Optimizing Companywide Counter-Generics Strategy and Navigating Biosimilar Competition

Chapter Benefits

  • Allow adequate planning time, pending the clinical or partnership needs for each counter-generics tactic.
  • Diversify counter-generic tactics to best drive a product’s sales and prolong its place in the market.
  • Understand and prepare for new biosimilar approval pathways in the US market, and compare US and EU regulations.
  • Plan biosimilar protection strategies to supplement biologics’ inherent protections.
  • Prepare for a growing biosimilar market and the increasing role of litigation in protecting biologic companies’ intellectual property.

Key Metrics

20 charts detailing the prevalence of each of 13 counter-generics strategies among surveyed companies — and insight into the emerging threat of biosimilar drugs.

  • Benefits of brand building versus price competition in counter-generics strategies
  • Percentage of all companies using specific counter-generic tactics
  • Ideal counter-generics strategy development timeline
  • Prevalence of all counter-generics tactics for all companies
  • Prevalence of counter-generics strategy type (exclusivity extension, competitive or line extension) by company type (Top 10, Top 50 and small companies)
  • Biologics and biosimilars regulatory timeline
  • Comparison of biosimilar regulations in the US and EU
  • Percentage of biologics and small-molecule drug companies using each counter-generics tactic


Chapter 6: Company-Specific Counter-Generics Strategy Profiles

Chapter Benefits

  • Benchmark counter-generics teams against departments with similar structures and size.
  • Compare counter-generics strategy timelines against companies using similar tactics.
  • Review profiles across company sizes:
    • Five (5) Top 10 pharma
    • Two (2) Top 50 pharma
    • Three (3) Small pharma

Key Metrics

10 profiles detailing real-world counter-generics teams:

  • Company background
  • Team structure and staffing
  • Companywide counter-generics strategy
  • Counter-generics strategy timeline

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 (available in the full report). Similarly, 49% plan to use defensive pricing between 2011 and 2013 (seen in Figure 1.29 (available in the full report)). 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.

Biosimilar and Counter-Generics Report Excerpt

 

The following excerpt is a key finding from the full report’s Executive Summary.

Biologic Companies Use Counter-Promotion Tactics To Combat Biosimilars

The popularity of specific counter-generics and counter-biosimilar tactics differs across biologic and small-molecule companies. Figure E.8 [shown in full report] shows the prevalence of examined tactics among these two types of drug companies. Counter-promotion is the most popular counter-biosimilar tactic used by surveyed biologic lifecycle management teams. More than half (56%) of surveyed biologic teams currently use this tactic. Among those teams, 80% report increasing advertising near and after patent expiration. A large difference in biologic and small-molecule tactic lies in the authorized generic deals. No surveyed biologic teams currently use this tactic, while a fifth of small-molecule teams do. This tactic is not likely to become popular for biologic teams — finding a company with the technology and infrastructure needed to create biosimilars will remain difficult in the near future.

Counter-promotion is particularly suited to biologic drugs facing biosimilar competition. Executives discussed the dangers of switching to a drug that may not be structurally identical, as is the case with small-molecule generics. The size and complexity of biologics make biosimilar introduction inherently more difficult. For payers’ and physicians’ benefit, biologic lifecycle management teams should highlight the risk of switching to a drug that is not generic, only similar.