Evens Ronald P
AAPS J. 2016 Jan;18(1):281-5. doi: 10.1208/s12248-015-9833-6.
The biotechnology segment of the overall biopharma industry has existed for only about 40–45 years, as a driver of new product development. This driving force was initiated with the FDA approval of recombinant human insulin in 1982, originating from the Genentech company. The pharma industry in the early years of 1970s and 1980s engaged with biotechnology companies only to a small extent with their in-licensing of a few recombinant molecules, led by Roche, Eli Lilly, and Johnson and Johnson. However, subsequently and dramatically over the last 25 years, biotechnology has become a primary driver of product and technology innovation and has become a cornerstone in new product development by all biopharma companies. This review demonstrates these evolutionary changes regarding approved products, product pipelines, novelty of the products, FDA approval rates, product sales, financial R&D investments in biotechnology, partnerships, mergers and acquisitions, and patent issues. We now have about 300 biotechnology products approved in USA covering 16 medical disciplines and about 250 indications, with the engagement of 25 pharma companies, along with their biotechnology company innovators and partners. The biotechnology pipeline involves over 1000 molecules in clinical trials, including over 300 molecules associated with the top 10 pharma companies. Product approval rates by the FDA for biotechnology products are over double the rate for drugs. Yes, the R&D paradigm has changed with biotechnology now as one of the major focuses for new product development with novel molecules by the whole biopharma industry.
作为新产品开发的驱动力，整个生物制药行业中的生物技术领域仅存在了约40 - 45年。这一驱动力始于1982年美国食品药品监督管理局（FDA）批准基因泰克公司生产的重组人胰岛素。在20世纪70年代和80年代早期，制药行业与生物技术公司的合作程度有限，仅对少数重组分子进行了引进许可，罗氏、礼来以及强生公司处于主导地位。然而，在随后的25年里，生物技术发生了巨大变化，已成为产品和技术创新的主要驱动力，并成为所有生物制药公司新产品开发的基石。本综述展示了在已批准产品、产品管线、产品新颖性、FDA批准率、产品销售、对生物技术的研发资金投入、合作关系、并购以及专利问题等方面的这些演变。目前，美国已批准约300种生物技术产品，涵盖16个医学学科和大约250种适应症，涉及25家制药公司及其生物技术创新公司和合作伙伴。生物技术产品管线中有1000多种分子正在进行临床试验，其中包括与排名前十的制药公司相关的300多种分子。FDA对生物技术产品的批准率是药物批准率的两倍多。的确，随着生物技术如今成为整个生物制药行业开发新型分子新产品的主要重点之一，研发模式已经发生了变化。
