Important Reminders for Pharmacists on ‘Generic Equivalency and Biosimilarity’

Shao C. Chiang reported for Taiwan Society of Health-System Pharmacists

On November 7th of 2015, Taiwan Pharmacy International Collaboration Center held its first conference in Kaohsiung, Taiwan, which focused on the quality of generics and biosimilars. The purpose of this meeting is to raise the alertness of pharmacists in taking their responsibility as a gatekeeper for patients in selecting appropriate generic and biosimilar products.

The conference lasted for 8 hours and covered eight topics in which the speakers were from different countries, including Australia, China, Germany, Taiwan, and the United States of America. The total number of participants was estimated around one hundred and fifty, who were mainly pharmacists working in hospital pharmacy, government agencies, and pharmaceutical companies.

Dr. Peter Pitts, the president of the Center for Medicine in the Public Interest and the former Associate Commissioner in the United States Food and Drug Administration, spoke to the audience with the topic “the Urgency of Quality & Innovation”, and mentioned that innovation is necessary, but is slow, hard, and expensive; the new drugs are usually expensive but actually they really increase the life expectancy and have been conservatively estimated as bringing benefits worth more than US$ 500 billion a year in United States. After the expiration of the patents, generic substitutions came into the market and it is difficult to know whether the money saved on the initial drug will still be saved. There are three current major strategies in improving the control of drug quality in US FDA: 1) the establishment of Office of Pharmaceutical Quality to strengthen pharmaceutical quality on a global scale; 2) urgent role of 21st century pharmacovigilance; 3) outcome-based bioequivalence and biosimilarity.

Drs. Shao Chiang from Koo Foundation Sun Yat-Sen Cancer Center, Taiwan and Jinhai Shi from Tianjin International Joint Academy of Biotechnology and Medicine, China reported their observations of the generic & biosimilar pharmaceutical quality in Taiwan and China. Drs. Li-Heng Pao from Graduate Institute of Health-Industry Technology, Chang Gung University of Science and Technology, Taiwan and Xiujuan Fu from the Second Affiliated Hospital of Jilin University, China provided a thorough overview on the quality assurance of generic drug products in Taiwan and China.

Mr. Jau-Jie Huang from the Ministry of National Health Insurance, Taiwan presented the reimbursement policy for generic products. The most controversial issue on the reimbursing the products marketed more than 15 years in Taiwan was discussed. Ms. Lizhen Hsu from Chanhua Christian Hospital, Taiwan and Dr. Juan Xie from Guizhou Provincial People’s Hospital, China both shared the evaluating and purchasing criteria for generic drugs in their institutions.

Dr. Andreas Groll from Wilhelms University, Germany reviewed the structures, components, and characteristics of liposomal products and what determines the efficacy and safety of liposomal products. Although EU and US already published their guidance on liposomal generic products, the issue on evaluating two liposomal products with same active ingredient still requires further efforts.

Dr. Churn-Shiouh Gau, Executive Director of Taiwan Center for Drug Evaluation, focused on the development of biosimilars and the regulations according to different countries. She provided essential knowledge and criteria in comparing biosimilars. Finally, Dr. Antonio Pires from Janssen Medical Affairs used Remicade (infliximab) and its biosimilars as an example to illustrate the complexity of biosimilars in terms of clinical aspects.

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