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Datamonitor Biosimilars in Emerging Markets (2017)

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April 21, 2017
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Follow-on biologics have been embraced enthusiastically in most emerging markets, where they promise to deliver much-needed improvements in access to a generation of products that remains beyond the reach of many patients. They have been registered in substantial numbers, and have been prescribed and purchased widely, expanding treatment populations and eroding originator revenues. By the early part of this decade, follow-on biologics were generating annual sales of around $600m in China alone. With follow-on products winning key government tenders in countries like Mexico and Russia, and being purchased by a growing number of patients in self-pay markets such as India, aggregate sales of copy biologics in the six BRIC-MS (Brazil, Russia, India, China, Mexico, and South Korea) countries now almost certainly exceed $1.5bn.

Many follow-on biologics being sold in BRIC-MS countries were subject to cursory regulatory reviews, and would not meet biosimilarity standards required to obtain marketing authorization in highly regulated markets. Some have been tested more rigorously, however, and manufacturers based in South Korea and India have begun to emerge as major players on the global biosimilars stage. In the meantime, regulators in all six BRIC-MS countries have introduced new, more rigorous requirements for the approval of follow-on biologics. These will trigger a degree of restructuring in most emerging biosimilar markets, piquing the interest of international players. BRIC-MS policymakers are keen to encourage the development of local manufacturing capabilities in the biologics sector, however, and foreign companies attempting to service emerging markets via biosimilar imports will face challenging administrative, regulatory, and pricing barriers.

Throughout this report, the term "follow-on biologic" is used generically, referring to any non-originator biologic, whether "biosimilar" or not. Despite its title, the report includes information on products that could not be described accurately as "biosimilars," a term reserved by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for biological medicines that are "similar to another biological medicine already authorized for use." To obtain an EMA or FDA marketing authorization, a biosimilar application must contain data showing that the product is "similar to the reference medicine" and that there are "no meaningful differences" between the two products in terms of quality, safety, or efficacy.

Early follow-on biologics commercialized in most BRIC-MS countries were subject to much less onerous requirements, and many would fail the EMA’s or FDA's biosimilarity test. These are often described as "copy biologics." Regulators in all six BRIC-MS markets have since implemented much tighter requirements governing the approval of follow-on products, however. While these refer variously to "biological products" (Brazil), "similar biologics" (India), or "biocomparables" (Mexico), all now require the production of substantive clinical data. In most cases this includes comparability data and, as such, it is reasonable to describe products approved under these new regulatory frameworks as biosimilars.

Disease Group Covered: Allergy
Autoimmune/immunology
Cardiovascular
Dermatology
Endocrine
ENT/Dental
Gastroenterology (non inflammatory bowel disease)
Hematology
Infectious disease
Metabolic
Neurology
Not Specified
Obstetrics/Gynecology
Oncology
Ophthalmology
Orthopedics
Psychiatry
Renal
Respiratory
Rheumatology (non autoimmune)
Urology
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