{"product_id":"biosimilars-hiten-j-gutka-9783319996790","title":"Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development","description":"\u003cp\u003eThis book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. \u003c\/p\u003e \u003cp\u003eFor the ease of readers, the book comprises of six sections as follows: \u003c\/p\u003e \u003cp\u003eSection I: Business, Health Economics and Intellectual Property Landscape for Biosimilars\u003c\/p\u003e \u003cp\u003eSection II: Regulatory Aspects of Development and Approval for Biosimilars\u003c\/p\u003e \u003cp\u003eSection III: Biopharmaceutical Development and Manufacturing of Biosimilars\u003c\/p\u003e \u003cp\u003eSection IV: Analytical Similarity Considerations for Biosimilars\u003c\/p\u003e \u003cp\u003eSection V: Clinical aspects of Biosimilar Development\u003c\/p\u003e \u003cp\u003eSection VI: Biosimilars- Global Development and Clinical Experience\u003c\/p\u003e \u003cp\u003eChapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Hiten J. Gutka\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 3319996797\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9783319996790\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Springer\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 12\/29\/2018\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 709\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Hardcover\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 2.64lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.21h x 6.14w x 1.56d","brand":"Hiten J. Gutka","offers":[{"title":"Hardcover","offer_id":46747681030399,"sku":"9783319996790","price":199.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_64a536da-e9db-44b6-81b1-9aec7aba433f.jpg?v=1743584420","url":"https:\/\/www.whiterainbookhouse.com\/products\/biosimilars-hiten-j-gutka-9783319996790","provider":"WR Book House","version":"1.0","type":"link"}