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Biosimilars and Biologics
Published in Laszlo Endrenyi, Paul Jules Declerck, Shein-Chung Chow, Biosimilar Drug Product Development, 2017
Erwin A. Blackstone, Joseph P. Fuhr
H–W has succeeded in its efforts to encourage both competition and innovation. Drug development has continued. Thirty-five new drugs were approved by the FDA through December 3, 2014, compared to a yearly average of 24 for the 2003–2014 period (Loo, 2014). Further, Evaluate Pharma indicates that between 2014 and 2020, “The R&D pipeline is strong” (Loo, 2014). At the same time, generics have increased their share of all prescriptions. Specifically, in 1984 when H–W was enacted, only 19% of all prescriptions were for generics. The percentage increased to 33 in 1990, to 72 in 2008, and to 86 in 2013. Given that generics are sometimes 80% or 90% less expensive than the brand-name drug (Zirkelback, 2014), such a growth in generics is not surprising, and obviously it has increased access. Third-party payers have induced patients to use generics by having lower copays or by not putting the originator product on their formulary. Generic drugs have saved over a trillion dollars in health care costs between 2002 and 2011 (IMS, 2012). Biosimilar competition is also expected to result in substantial benefits.
Intellectual property issues for biosimilars
Published in Sarfaraz K. Niazi, Biosimilars and Interchangeable Biologics, 2016
Regulatory exclusivities are automatically granted upon new drug approval by the regulatory agency that licenses the product for commercial distribution (In its Draft Guidance Document entitled, Reference Product Exclusivity for Biological Products Filed Under §351(a) of the PHS Act (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM407844.pdf) the FDA has proposed that the applicant include in its 351(a) application a request for reference product exclusivity. More specifically, the FDA recommends that the applicant provides an explanation how the biological product meets the statutory requirements for exclusivity and submits adequate data and information to support the request). These exclusivities provide pharmaceutical companies with an incentive to undertake the risk and capital investment required to develop and obtain regulatory approval for drug and biologic products. Innovator companies requested this type of exclusivity during the negotiations that accompanied the enactment of the 1984 Drug Price Competition and Patent Term Restoration Act (more commonly known as the Hatch-Waxman Act), which defined the approval pathway that created the generic pharmaceutical market in the United States (§505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)). Innovator companies grounded their request on the premise that the award of an exclusivity period would provide greater certainty that the financial investments required to develop a new drug would be repaid. Congress has characterized the regulatory exclusivities as a quid pro quo for the practice of allowing generic companies to file an abbreviated approval package focused on establishing that the proposed generic a “bioequivalent” to the originator’s product and making reference to, and relying on, the clinical package of the originator’s product to establish safety and efficacy. Note that generic manufacturers obtain regulatory approval by filing an Abbreviated New Drug Application (ANDA) and by submitting data establishing the bioequivalence of the generic drug, without additional safety or efficacy data.
Benchmarking green chemistry adoption by the Indian pharmaceutical supply chain
Published in Green Chemistry Letters and Reviews, 2018
Vesela R. Veleva, Berkeley W. Cue, Svetlana Todorova, Harshrajsinh Thakor, Nitesh H. Mehta, Krishna B. Padia
The global pharmaceutical industry had $996 billion in sales in 2017 (17) and is projected to reach $1.12 trillion by 2022 (18). Sales of pharmaceuticals are expected to grow at 6.3% annually over the next several years as result of aging population and increasing healthcare spending globally. United States remains the world’s largest market for prescription medicines with 45% of the global market. Six of the top 10 largest pharmaceutical companies globally are U.S. based research and development (R&D) pharma (19). The sector comprises four main segments: innovative pharmaceutical industry (also known as R&D pharma), biopharmaceutical industry, biologics, and generic pharmaceutical industry (20). Generic drug companies make copies of brand name drugs after expiration of their patents, which are identical in terms of API, strength dosage and route of administration (20). The global market for generic drugs reached $200 billion in 2015 and is projected to grow at 10.8% over the next several years, reaching $380 billion by 2021 (21). China and India have emerged as the leading markets for manufacturing API and R&D outsourcing due to their cost advantage and highly educated workforce. Manufacturing costs in India are estimated to be 30–40% lower than those in the United States and Western Europe, and labor costs – one seventh of those in the U.S. (22). In addition, the costs of running an FDA-inspected manufacturing plant in India have been found to be 50% lower than in developed countries (22).