Introduction:
Since the launch of the first biosimilar human growth hormone (hGH) in
2006, biosimilars have become increasingly important to pharmaceutical companies
as they try to protect revenue streams from their major brands. Previously,
branded biologics were protected from the type of generic erosion that
eventually faces all small-molecule therapies by the absence of an abbreviated
regulatory pathway for approval of biosimilars. As regulatory agencies have now
established, or are in the process of establishing, pathways for approval of
biosimilars, companies marketing major biologic brands need to characterize and
account for impending competition.
This report forecasts the impending erosion faced by the following biologic
drugs used to treat hepatitis C virus (e.g., interferon [IFN]-alphas) and
immune disorders including Crohn’s disease, ulcerative colitis and rheumatoid
arthritis (e.g., tumor necrosis factor-alpha [TNF-α] inhibitors).
- IFN-alphas—for
example, Schering-Plough’s Intron A (IFN-alfa-2b) and Peg Intron (pegylated IFN-alfa-2b);
Roche’s Pegasys (pegylated IFN-alpa-2a).
- TNF-α
inhibitors—for example, Amgen’s Enbrel (etanercept), Abbott’s Humira (adalimumab),
and Centocor Ortho Biotech/Schering-Plough’s (infliximab).
Biologics today are some of the most effective agents on the market, and
yet many are also the most expensive agents available. Managing the costs
associated with TNF-α inhibitor therapy, in particular, is a concern
shared by payers, physicians, and patients. The prospect of lower cost
biosimilars in gastroenterology and rheumatology has created a balancing act
between payers’ desire to limit spending on chronic therapies and physicians’ demand
for clinical proof of biosimilars’ equivalent efficacy versus branded reference
agents. This report uses our extensive primary research with U.S. and European specialists as well as U.S. payers to highlight the key expectations of each
stakeholder that will drive or constrain biosimilar adoption.
Questions Answered in This Report:
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Payer perspectives: We gathered survey data from 41 U.S. pharmacy and medical directors detailing their outlook on biosimilar adoption and the impact
biosimilars will have on their business.
Which classes of drugs most concern
payers, and how will payers encourage uptake of biosimilars to reduce spending
in these classes? Which reimbursement controls will payers use most often, and
how do payers expect physicians to react to these controls?
*
Physician perspectives: Our survey of 75 gastroenterologists and 78
rheumatologists across France, Germany, and the United States reveals that expected
uptake of biosimilars among rheumatologists and gastroenterologists differs by
drug class and indication.
What clinical and commercial features of
biosimilars will most strongly drive and/or constrain uptake of biosimilars
among gastroenterologists and rheumatologists? Which tactics can makers of
branded biologics use to encourage physicians to continue prescribing branded
agents instead of biosimilars? How susceptible are gastroenterologists and
rheumatologists to these tactics, compared with other physicians?
*
Market forecast: Across the U.S. and EU5 markets, we project biosimilars
of TNF-α inhibitors covered in this report will erode $9.6 billion in
brand sales, saving the healthcare system $4.0 billion in the process. We forecast
more modest erosion of brand sales in the hepatitis C virus market, with a loss
of $500 million in brand sales attributable to biosimilar IFN-alphas.
Which
brands will see the most dramatic biosimilar erosion? How will biosimilar
erosion of brands used in gastroenterology and rheumatology compare with that
of brands used in other therapeutic areas? How will reference pricing affect
biosimilar erosion of branded sales differently in Europe than in the United States?Scope:
Markets covered: United States, France, Germany, Italy, Spain, and United Kingdom.
Primary research—Physicians: Surveys with 75 gastroenterologists and 78
rheumatologists across the United States, Germany, and France, each with at
least three years experience post-residency.
Primary research—Payers: Surveys with 41 U.S. pharmacy and medical directors,
each with at least three years experience on their plan’s Pricing and
Therapeutic Committees and each responsible for at least 100,000 covered lives.
Market forecast features: Annualized, 11-year market forecast
(2008-2018) with full transparency of forecasting assumptions. Class-level
biosimilar trends to allow clients to see how biosimilar erosion of their brand
compares with that of their closest competitors and to facilitate informed
choices on which analogues are most appropriate for forecasting a given brand.
Timeline for biosimilar entry in the major markets, with key challenges
resulting from the current and anticipated regulatory environment. Custom
forecasting tool with our complete forecasts that allows user modification.