Ross Malcolm S F
Generapharm-Training and Consultancy, Rümelinbachweg 16, Basel, Switzerland.
IDrugs. 2010 Apr;13(4):243-7.
Pharmaceutical companies that market generic products generally are not regarded as innovators, but rather as companies that produce copies of originator products to be launched at patent expiration. However, many generics companies have developed excellent scientific innovative skills in an effort to circumvent the defense patents of originator companies. More patents per product, in terms of both drug substances (process patents and polymorph patents) and formulations, are issued to generics companies than to companies that are traditionally considered to be 'innovators'. This quantity of issued patents highlights the technical knowledge and skill sets that are available in generics companies. In order to adopt a completely innovative model (ie, the development of NCEs), a generics company would require a completely new set of skills in several fields, including a sufficient knowledge base, project and risk management experience, and capability for clinical data evaluation. However, with relatively little investment, generics companies should be able to progress into the so-called 'supergeneric' drug space - an area of innovation that reflects the existing competencies of both innovative and generics companies.
销售仿制药的制药公司通常不被视为创新者,而是被看作是在专利到期时生产原创产品仿制品的公司。然而,许多仿制药公司已经培养了出色的科学创新技能,以努力规避原创公司的防御性专利。与传统上被视为“创新者”的公司相比,仿制药公司在药物物质(工艺专利和多晶型专利)和制剂方面,每个产品获得的专利更多。已颁发专利的数量凸显了仿制药公司所具备的技术知识和技能组合。为了采用完全创新的模式(即开发新化学实体),仿制药公司在几个领域需要一套全新的技能,包括足够的知识基础、项目和风险管理经验以及临床数据评估能力。然而,通过相对较少的投资,仿制药公司应该能够进军所谓的“超级仿制药”领域——这是一个反映创新型公司和仿制药公司现有能力的创新领域。