Blackstone Erwin A, Joseph P Fuhr
Professor of Economics, Temple University, Philadelphia, PA.
Professor of Economics, Widener University, Chester, PA.
Am Health Drug Benefits. 2013 Sep;6(8):469-78.
The high cost of pharmaceuticals, especially biologics, has become an important issue in the battle to control healthcare costs. The Hatch-Waxman Act encourages generic competition but still provides incentives for pioneers to develop new drugs. The Biologics Price Competition and Innovation Act is intended to do the same for biologics and biosimilars.
To examine information related to biosimilars to determine their potential impact on competition in the biologic market.
Using information concerning the European Union (EU) and the pharmaceutical industry, this article reviews and analyzes the experience of biosimilars in the EU, as well as the obstacles and opportunities that biosimilars face in the United States. Much of the analysis is based on examining current trends in biologic drugs and the potential implications on the future of biosimilars.
This article reviews the mixed success of biosimilars in the EU and the implications for the United States. Because biologics are produced from living organisms, manufacturing issues are more important than in the chemical drug market. The barriers to biosimilar entry into the marketplace are much more difficult to overcome than challenges generic manufacturers typically face and are similar to obstacles specialty injectable producers encounter. The competitive responses by pioneers are also likely to be more important. The capital costs and risk issues with biosimilars make alliances and partnering arrangements very likely. Biosimilars often enter emerging markets, where the barriers to entry are easier to overcome. Nevertheless, the United States represents the greatest opportunity for biosimilar producers, in part because it is the largest biologics market and has high prices for biologics. As the United States enters the biosimilar market, the pharmaceutical industry is likely to grow at an accelerated pace. Automatic substitution is likely to be slow to develop, because of safety and quality concerns. The beneficial impact of biosimilars is likely to take a long time to be realized and to be fraught with more difficulties than was the case for small-molecule generics.
Various factors, such as safety, pricing, manufacturing, entry barriers, physician acceptance, and marketing, will make the biosimilar market develop different from the generic market. The high cost to enter the market and the size of the biologic drug market make entry attractive but risky.
药品，尤其是生物制品的高昂成本，已成为控制医疗成本斗争中的一个重要问题。《哈奇-沃克斯曼法案》鼓励仿制药竞争，但仍为原研药开发商提供研发新药的激励措施。《生物制品价格竞争与创新法案》旨在对生物制品和生物类似药起到同样的作用。
研究与生物类似药相关的信息，以确定它们对生物制品市场竞争的潜在影响。
本文利用有关欧盟和制药行业的信息，回顾并分析了生物类似药在欧盟的经验，以及生物类似药在美国面临的障碍和机遇。大部分分析基于对生物制品药物当前趋势及其对生物类似药未来潜在影响的研究。
本文回顾了生物类似药在欧盟的喜忧参半的成果及其对美国的影响。由于生物制品是由活生物体生产的，生产问题比化学药品市场更为重要。生物类似药进入市场的障碍比仿制药制造商通常面临的挑战更难克服，与专业注射剂生产商遇到的障碍类似。原研药厂商的竞争反应可能也更为重要。生物类似药的资本成本和风险问题使得联盟和合作安排很有可能出现。生物类似药通常进入新兴市场，那里的进入壁垒更容易克服。尽管如此，美国对生物类似药生产商来说是最大的机遇，部分原因在于它是最大的生物制品市场，且生物制品价格高昂。随着美国进入生物类似药市场，制药行业可能会加速增长。由于安全和质量方面的担忧，自动替换可能发展缓慢。生物类似药的有益影响可能需要很长时间才能实现，且比小分子仿制药面临更多困难。
安全、定价、生产、进入壁垒、医生接受度和营销等各种因素将使生物类似药市场的发展不同于仿制药市场。进入市场的高成本和生物制品药物市场的规模使得进入该市场具有吸引力但也有风险。
