title: Towards regulation of similar biotherapeutic products: Thailand's perspective.
abstract: The implementation of universal health coverage scheme in Thailand allows quality, equitable and accessible health care for all. Patients with life threatening and chronic diseases can get access to biotherapeutic products to treat their ailments. This triggered a major impact on the need for specific guidelines in evaluation of similar biotherapeutic products in order to standardize the regulatory pathway to license this class of products ensuring that the products meet acceptable levels of quality, safety and efficacy. The development of similar biotherapeutic products (SBP) should be considered to ensure therapeutic equivalence of biotherapeutics products at more affordable prices. This will lead to greater ease and speed of approval and assurance of the quality, safety and efficacy of these products. Therefore, we report herein the SBP situation in Thailand.
authors.affiliation: Bureau of Drug Control, Thai Food and Drug Administration, Ministry of Public Health, Nonthaburi, Thailand. passorn@fda.moph.go.th
authors.forename: Prapassorn
authors.initials: P
authors.lastname: Thanaphollert
authors.forename: Kriang
authors.initials: K
authors.lastname: Tungsanga
mesh_terms: D017277:Drug Approval; D004341:Drug Evaluation / Q000191:economics / Q000592:standards*; D004345:Drug Industry / Q000191:economics / Q000331:legislation & jurisprudence* / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D008004:Licensure; D004364:Pharmaceutical Preparations / Q000191:economics / Q000592:standards*; D011786:Quality Control; D013785:Thailand
chemical_list: D004364:Pharmaceutical Preparations