ArticlePloS one2019
The implementation of the bioequivalence certification policy in Chile: An analysis of market authorization data.
Article in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Comparative Toxicity of Interferon Beta-1a Impurities of Heavy Metal Ions.Medicina (Kaunas, Lithuania) · 2022Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAffordability 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.
objectiveTo study the implementation of the bioequivalence certification policy in Chile.
methodsWe 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.
resultsAs 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.
conclusionsAlthough 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.
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Registered trials
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