the impact of biosimilars on the future of u.s. pharmaceutical industry
TRANSCRIPT
Biosimilars and the U.S. Pharmaceu5cal Industry: Impact and Outlook
Bharat Bharat Crea%ve Entrepreneur & Consultant
Biosimilars are biological products similar to original biologic
The FDA defines biosimilar as a biological product that:
• is highly similar to a FDA-‐approved reference biological product,
• has minor differences in clinically inac5ve components,
• and has no clinically meaningful difference between itself and the reference product in terms of safety, purity, and potency of the product.1
2
Biosimilars will have high impact on the U.S. pharmaceu5cal industry by 2020 • $67B worth of patents (12 blockbuster
drugs) expiring before 20201
Major players affected: • Regulatory bodies (FDA) • Original drug manufacturers • Payers • Providers • PaBents
Poten5al impact: • Increased compeBBon & innovaBon • Market share diversificaBon • GeneraBon of new drugs • Lower future biologic costs • BeIer regulatory and financial procedures
2
3
4
Savings of $250B from 11 upcoming biosimilars in the next 10 years will improve payer cost savings and promote biosimilars
Biosimilars sold at 20%-‐30% discount to the price of
original biologics1
Provide higher cost savings, lower reimbursements, and lower cost sharing to payers3
Reduce healthcare costs by $250B; Increase pa5ent
access to biologic treatments by providing lower cost
alterna5ves2
Increased payer incenBve to promote biosimilars to providers and paBents by using new Bered formularies, innovaBve fee schedules,
and markeBng iniBaBves3
4
Biosimilar safety and efficacy data plus provider confidence will lead to increased biosimilar acceptance and visibility
Biosimilars sold at 20%-‐30% discount to the price of original biologics
Increase pa5ent access to biologic treatments by providing lower cost
alterna5ves
Providers incenBvized to prescribe biosimilars to paBents for acute, hospitalized condiBons 3
FDA Approved and Interchangeable with original biologics; Proven safety and efficacy records to build provider trust1
Providers reimbursed average sales price (ASP) of biosimilar + 6% ASP of original biologic2
Efficacy
Safety Regulatory
Biosimilar Cost
Provider Trust &
Confidence
Recent survey predicts posiBve uptake of biosimilars by payers & providers despite current market barriers & regulatory challenges1
Survey conducted in 2011 at Na%onal Comprehensive Cancer Network Annual mee%ng consis%ng of 277 physicians, payers, pharmacists, and nurses2
Payer’s PerspecBve Provider’s PerspecBve
Biosimilars reduce costs and provide greater paBent access to alternaBve treatments. This makes them a lucraBve opBon for payers, providers, paBents, & the U.S. pharmaceuBcal market by 2020.
Sources Slide 1: 1: "U.S. Food and Drug Administra5on." Biosimilars. 2: Biologics and Biosimilars: An Overview (2014): Amgen.
Slide 2: 1: US$67 Billion worth of Biosimilar Patents Expiring before 2020 Posted 29/06/2012.” Web. 25 Mar. 2015. 2: Fernandez, Bruno C., and Juan L.M. Hurtado. "Biosimilars: Company Strategies to Capture Value from the Biologics Market." Pharmaceu5cals (2012): 1393-‐408. Web. 3: Shaping the Biosimilars Opportunity: (2011): IMS Health. 4: Buffery D. Am Health Drug Benefits. 2011;4:120.; "The U.S. Biosimilars Market: Threats and Opportuni5es.” Dean & Company.
Slide 3: 1: "Shaping the Biosimilars Opportunity: A Global Perspec5ve.” IMS Health. 2: "Shaping the Biosimilars Opportunity: A Global Perspec5ve.” IMS Health. 3: Falit, Benjamin P., Surya C. Singh, and Troyen A. Brennan. "Biosimilar Compe55on In The United States: Statutory Incen5ves, Payers, And Pharmacy Benefit Managers." Health Affairs. 4: “The $250 Billion Poten5al of Biosimilars” Industry Update, Express Scripts, April 23, 2013 at hmp://lab.expressscripts.com/insights/industry-‐updates/the-‐$250-‐billion-‐poten5al-‐of-‐biosimilars. And “Infographic_Need_for_Biosimilars”
Slide 4: 1: "Shaping the Biosimilars Opportunity: A Global Perspec5ve.” IMS Health. 2: "Biosimilar Reimbursement Under The Sequester: The Lower The Price, The Bigger The Spread :: Pharma & Medtech Business Intelligence.” hmps://www.pharmamedtechbi.com/publica5ons/rpm-‐report/first-‐take/2014/5/biosimilars-‐and-‐sequester 3: "How Biosimilars Track a Unique Sales Path." ZS Associates, 2014.
Slide 5: 1: "Barriers to Market Uptake of Biosimilars in the US -‐ GaBI Journal." GaBI Journal. And "The U.S. Biosimilars Market: Threats and Opportuni5es.” Dean & Company. 2: "Barriers to Market Uptake of Biosimilars in the US -‐ GaBI Journal." GaBI Journal.
Analysis by: Bharat Bharat
Crea%ve Entrepreneur & Consultant