Research Article: The implementation of the bioequivalence certification policy in Chile: An analysis of market authorization data

Date Published: May 29, 2019

Publisher: Public Library of Science

Author(s): Warren A. Kaplan, Jorge Cárdenas, Cristián Mansilla, Tatiana Tobar, Veronika J. Wirtz, Eduard J Beck.


Affordability is a key barrier to access to medicines. Generic medicines policies can address this barrier and promote access. Successful uptake of generic medicines depends, in part, on ensuring that these products are interchangeable with reference products. Typically, bioequivalence certification is established in order to demonstrate such interchangeability.

To study the implementation of the bioequivalence certification policy in Chile.

We used Chilean Market Regulatory Authority data for analysis to study the number of products that obtained bioequivalence certification, the time until bioequivalence certification and associated factors to obtain bioequivalence.

As of January 2017, out of 2,336 products with a valid market authorization containing at least one of the 167 APIs that required BE certification, 1,026 products actually have BE certification (1,026/2,336, 43.9% compliance). Where data were available, the time between submission of the market authorization as a bioequivalent product to final authorization by the national medicine regulatory authority for most products varied between 4–6 months. The fraction of all BE products containing a given API out of the total marketed products containing that API varies considerably, e.g. for the API olmesartan there was only a single BE product marketed, the API diclofenac had none.

Although the implementation of Chile’s bioequivalence policy increased the number of bioequivalent products, over 50% of generic products requiring bioequivalence that did not obtain this certification. Also for some of the API none or very few BE products are marketed which limits the success of a substitution policy. Further studies are required to identify the apparent lack of incentives to obtain bioequivalence certification. Studies of sales volumes and prices of the products are needed to identify whether generic products without bioequivalence certification either become bioequivalent or eventually exit the market.

Partial Text

Price is one of the major barriers to access to medicines. [1] An increasing number of countries have implemented generic medicines policies to promote medicines access as they move towards Universal Health Coverage, in large part because generic medicines are usually less expensive than the innovator medicines [2]. According to the World Health Organization (WHO), generic medicines are a “pharmaceutical product, usually intended to be interchangeable with the innovator product, which is usually manufactured without a licence from the innovator company and marketed after the expiry of patent or other exclusivity rights.”[3] It is called an “unbranded generic” when it is sold under (international) non-proprietary name (INN). If sold under a brand name, it is a “branded generic”. An “innovator product” is “generally the pharmaceutical product which was first authorized for marketing (normally as a patented product) on the basis of documentation of efficacy, safety and quality according to requirements at the time of the authorization.” [3]

Fig 1 below shows the number of different APIs deemed BE in a given year starting in March 2009 until 2017. The other bars show the cumulative total of all APIs in that year as well as the total BE products in that particular year for all APIs. There were 2,336 products with a valid market authorization containing at least one of the 167 APIs that required BE certification. Of those products, 1,026 products have BE certification (1,026/2,336, 43.9%, compliance).

This study of the implementation of the Chilean bioequivalence policy provides insight into the extent of uptake of bioequivalent products and the factors related to their uptake. We note the number of new APIs added by decree increased over time as did the cumulative number of registered BE products. Many important therapeutic groups such as analgesics and cardiovascular medicines had a high number of products with BE certification, potentially providing patients with lower priced products compared to the innovator products.

Implementation of Chile’s BE policy increased number of BE products although there is still some distance to go to attain BE for all products and remove non-BE products from the market. Also for some of the API none or very few BE products are marketed which limits the success of a substitution policy. From an administrative viewpoint, continued monitoring and transparency in the BE registration process would be important. It is encouraging that important therapeutic groups contain products that are now BE.