{"product_id":"9781611220766","title":"Follow-On Biologics","description":"A biologic is a preparation, such as a drug or a vaccine, that is made from living organisms. A follow-on biologic, or biosimilar, is similar to the brand-name (innovator) product made by the pharmaceutical or biotechnology industry. In contrast to a biologic, most commonly used drugs are synthesised via a chemical process. Biologics often require special handling (such as refrigeration) and are usually administered to patients via injection or infused directly into the bloodstream. This book provides a brief introduction to the relevant law, the regulatory framework at the FDA, the scientific challenges for the FDA in considering the approval of follow-on biologics, and a brief description of the biologics provisions in the new healthcare reform bill signed into law under President Obama, entitled the Patient Protection and Affordable Care Act (PPACA).","brand":"Nova Science Publishers, Inc (US)","offers":[{"title":"Default Title","offer_id":65427111313757,"sku":null,"price":139.49,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1041\/3893\/2573\/files\/9781611220766.jpg?v=1789397455","url":"https:\/\/shop.gazellebookservices.co.uk\/products\/9781611220766","provider":"Gazelle Book Services","version":"1.0","type":"link"}