Follow-On Biologics
Biologics comprise one of the fastest growing and most expensive categories of drugs.
By 2009, sales are estimated to reach $90 billion and according to published reports, an estimated $10 billion worth of biologic drugs are expected to come off patent by 2010.*
Read more in the Latest Developments section.
The Promise of Follow-On Biologics: The Need to Match Policy with Capability and Demand
View Insmed CEO Geoffrey Allan's engaging presentation at the Center for Business Intelligence April 28-29, 2008 conference, "Evaluate the Legislative, Economic and Scientific Implications of the Industry Debate on:Biosimilars and Follow-On Biologics."
Insmed aims to be the first U.S. based Biotechnology Company to develop a comprehensive portfolio of follow on biologics. Members of Insmed's skilled team have worked on over 50 therapeutic proteins. Their focused scientific background coupled with our protein manufacturing capability and clinical and regulatory expertise positions Insmed to potentially be a leading company in the entry of the U.S. market with a broad range of follow on biologics when the patents covering the innovator products expire.
Follow-on biologics are versions of approved biologics that are developed after the original product has been created with the intention of marketing them after the patent on the innovator product has expired, thus bringing competition to monopolistic markets.
Biologics comprise one of the fastest growing and most expensive categories of drugs. It is estimated that 50% of approved pharmaceuticals in 2010 will be biotechnology products, with sales estimated to reach $90 billion.
According to published reports, an estimated $10 billion worth of biologic drugs are expected to come off patent by 2010 (with an additional $10 billion by 2015) but currently are immune from competition.* Follow-on biologics would provide safe and effective therapies at a reduced cost following the expiration of the original product's patent.
*Engel & Novitt, LLP, "Potential Savings That Might Be Realized by the Medicare Program From Enactment of Legislation Such as The Access to Life-Savings Medicine Act (H.R. 6257/S. 4016) That Establishes A New cBLA Pathway For Follow-On Biologics. Table 4a., January2, 2007.
Creating a Pathway
While an estimated $20 billion worth of biologic drugs are expected to come off patent by 2015,* no approval pathway currently exists at the Food and Drug Administration (FDA) to make follow-on biologics available to patients. Without this important pathway biotech companies will continue to have a monopoly and competition will not exist in the market. Without competition access to these critical medicines will remain expensive and will continue to drive up the overall healthcare expenditures in the US.
How would this pathway be created?
The 1984 The Drug Price Competition and Patent Term Restoration Act, or "Hatch-Waxman Act" established the modern system of generic drugs for pharmaceuticals.
Hatch-Waxman amended the Federal Food, Drug, and Cosmetic Act, establishing the process by which marketers of generic drugs can file Abbreviated New Drug Applications (ANDAs) to seek FDA approval to bring a generic product to market after the original patented has expired. As these generic drugs were exactly the same chemically to the innovator products, the generic manufacturers were not required to conduct clinical trials to support safety or efficacy.
Because biologics are larger proteins made from living cells, the end product is never the same due to the variability of the initial cell bank. To address this variability of the end product it is anticipated that the FDA will require abbreviated clinical testing to make sure that this variability from the innovator product does not adversely affect the safety and efficacy profile of the drug.
The European Union is ahead of the United States in this effort. The European Medicines Agency (EMEA) has already established guidelines for follow-on biologics and an existing 505(b)2 pathway does exist in the US which has been used in the past to approve follow on biologics. The FDA, employer coalitions, managed care organizations and health experts have asked Congress to formally establish a similar approval pathway for biologics in the US and a solution is now under discussion.
Insmed's Role
Insmed's goal is to be the first U.S.-based biotechnology company to develop a comprehensive portfolio of follow-on biologics. Members of Insmed's skilled biologics team have worked on over 50 therapeutic proteins. Their focused scientific background coupled with our sate of the art protein manufacturing capability, protein characterization and clinical and regulatory expertise positions Insmed to be a leading company in the entry of the U.S. market with a broad range of follow on biologics when the patents covering the innovator products expire.
Insmed CEO Geoffrey Allan has twice testified before the U.S. Congress on the importance of establishing an approval pathway for follow-on biologics.
The full text of his testimony is available here:
May 2, 2007 - House Committee on Energy and Commerce
"Assessing the Impact of a Safe and Equitable Biosimilar Policy in the United States"
March 26, 2007 - House Committee on Oversight and Government Reform
"Safe and Affordable Biotech Drugs - The Need for a Generic Pathway"
Insmed's Unique Positioning
Insmed has established itself as an expert in the development and manufacturing arena of biologics and is uniquely positioned to enter the follow-on biologics field.
Insmed has the scientific expertise, facilities and a proven ability to develop biotechnology products.
- With more than 600 years of collective experience working across the biotechnology industry, Insmed's staff has worked with over 50 therapeutic protein drug products.
- Insmed maintains a 50,000 sq. ft., state-of-the-art, FDA-approved Biologics Manufacturing Facility and Process and Analytical Laboratory in Boulder, CO.
The company's state-of-the-art manufacturing facility, Insmed Therapeutic Proteins (ITP), has already been FDA-inspected and approved for the commercial production of IPLEX™ for the Primary IGFD indication. Located in the biotech hub of Boulder, Colorado, ITP is a technological asset for Insmed. Given its advanced protein manufacturing capability, combined with a skilled work force, the company is positioned to leverage its process expertise in any number of new ventures, either through acquisitions or partnering activities.
The facility's potential for expanded capacity allows Insmed to be poised for production of follow on biologics.
In summary Insmed has:
- A deep scientific expertise in protein manufacture
- The capacity footprint in place now to manufacture our targeted follow-on biologics, and
- A thorough understanding of the clinical and regulatory pathway having already had a complex protein. IPLEX™ approved by the FDA.
It is the combination of these three critical success factors which we believe differentiates Insmed from the competition.
*Engel & Novitt, LLP, Potential Savings That Might Be Realized by the Medicare Program From Enactment of Legislation Such as The Access to Life-Savings Medicine Act (H.R. 6257/S. 4016) That Establishes A New cBLA Pathway For Follow-On Biologics. Table 4a., January 2, 2007.
