Related Experiment Video
Updated: Oct 6, 2025
07:25
In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
17.9K
Biosimilar competition: Early learning
Richard G Frank1, Mahnum Shahzad2, Aaron S Kesselheim3
1The Brookings Institution, Washington, District of Columbia, USA.
Health Economics
|January 13, 2022
Summary
Biosimilar competition, spurred by the Biological Price Competition and Innovation Act (BPCIA), has begun to lower biologic drug prices. Each new biosimilar entrant reduces prices, though not as much as initially anticipated.
Area of Science:
- Pharmaceutical Economics
- Health Policy
- Drug Pricing
Background:
- Biologics represent a significant and rapidly growing sector of the pharmaceutical market, with substantial healthcare spending.
- The Biological Price Competition and Innovation Act (BPCIA) of 2010 aimed to foster competition and reduce costs through biosimilar pathways.
- Initial expectations for significant price moderation following the BPCIA have not been fully realized.
Purpose of the Study:
- To investigate the early effects of biosimilar competition on the utilization and pricing of biologic products.
- To analyze how market structure changes, influenced by the BPCIA, impact biologic drug prices.
- To quantify the price reductions associated with biosimilar market entry.
Main Methods:
- Analysis of seven biologic products that have recently experienced biosimilar competition.
- Estimation of fixed effects and Instrumental Variables models to assess the relationship between market competition and prices.
- Focus on changes in market structure and their impact on pricing dynamics.
Main Results:
- Each additional marketed product, specifically biosimilars, leads to a weighted average market price reduction of 5.4% to 7%.
- This price moderation is attributed to both reduced originator prices and a shift in consumer demand towards biosimilar alternatives.
- The observed impact suggests a tangible, albeit moderate, effect of biosimilar competition on biologic pricing.
Conclusions:
- Biosimilar competition, facilitated by the BPCIA, is contributing to lower biologic drug prices.
- The market entry of biosimilars demonstrates a measurable impact on originator pricing and consumer choice.
- Further monitoring is warranted to fully understand the long-term economic implications of biosimilar adoption.
Related Concept Videos
01:28Drug Products: Biologics, Biosimilars and Interchangeables
5
Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
5
02:34Competition
22.8K
When organisms require the same limited resources within an environment, they may have to compete for them. Competition is a net-negative interaction. Even if two competing individuals or populations do not interact directly, the overall fitness of both competitors is lowered as a result of not having full access to the limited resource.
22.8K
01:16Bioequivalence: Overview
1.3K
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
1.3K
01:13Bioequivalence studies: Biowaivers
11
Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
11
01:22Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence
11
Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
11
01:19Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence
10
Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
10