What the patent dance of the Biosimilars Act means for biosimilars

2014 ◽  
Vol 20 (4) ◽  
Author(s):  
David A. Fazzolare ◽  
Joanna Brougher
Keyword(s):  
Price Competition ◽  
Market Entry ◽  
Patent Protection ◽  
Reference Product ◽  
Title Vii ◽  
President Obama ◽  
Biological Products ◽  
Related Information ◽  
The Us ◽  
Biologic Product

There are currently only two biosimilars on the market in the US in contrast to the 21 biosimilars have been approved in Europe since 2006. Part of the reason for the lack of biosimilars is that until recently, there has been no abbreviated pathway for a biosimilar to reach the market meaning that biosimilars had to undergo the long and costly process of obtaining approval just like an innovator biologic product. After years of negotiation, however, the Biologics Price Competition and Innovation Act (the “Biosimilars Act”) was signed into law on March 23, 2010, by President Obama as Title VII of the Patent Protection and Affordable Care Act. The Biosimilars Act established an abbreviated pathway by which the FDA could approve generic versions of previously licensed biological products. The Biosimilars Act sets forth several requirements for biosimilar applications, including the so-called “Patent Dance” which describes the process by which the biosimilar applicant and the reference product sponsor (“RPS”) exchange patent-related information before the biosimilar can enter the market. In this article, we will explore what the Patent Dance is and what it means for biosimilars that are seeking market entry in the US. 

Recognizing barriers to entry of biosimilars in the United States market and highlighting the solutions

2020 ◽  
pp. 174113432097215
Author(s):  
Arpit Bana ◽  
Priti J Mehta
Keyword(s):  
Patent Protection ◽  
Reference Product ◽  
Market Competition ◽  
The United States ◽  
Living Cells ◽  
Barriers To Entry ◽  
The Us ◽  
The Government ◽  
The Cost ◽  
The U.S

Drugs that are procured from living cells and are used to treat acute and chronic diseases are called biologics, whereas biosimilars are the drugs which are highly similar but not identical to the original reference product. The main advantage of these drugs is that they are highly targeted with great therapeutic activity and can be used for multiple indications. Despite all the advantages biologics are still extremely costly. The main purpose of developing and introducing biosimilars was and is to increase market competition leading to a decrease in the cost of the biologics. However, until now the cost of the treatment has not decreased in the US market because there are many barriers to the entry of biosimilar in the US market which are discussed in this article. In this article, we argue that the barrier or hurdle in the US market entry of the biosimilars is not only limited to patent protection or exclusivity but other less discussed barriers are also there which are to be discussed. Due to these barriers till June 10, 2020, only 9 biosimilars are available commercially in the US market out of the 27 biosimilars approved for marketing by the U.S. Food and Drug Administration (FDA). We argue that the introduction of these biosimilars in the US market is essential for increasing market competition and thus decreasing the overall treatment cost for both the government and the payers. In this article, we are also providing perspective on the possible solutions to reduce these barriers and to encourage the entry of biosimilar in the US market.

scholarly journals Clinical and treatment characteristics of patients treated with the first therapeutic oncology biosimilars bevacizumab-awwb and trastuzumab-anns in the US

2021 ◽  
Vol 13 ◽  
pp. 175883592110419
Author(s):  
Ran Jin ◽  
Reshma L. Mahtani ◽  
Neil Accortt ◽  
Tatiana Lawrence ◽  
Darcie Sandschafer ◽  
...  
Keyword(s):  
Market Entry ◽  
Reference Product ◽  
Early Stage ◽  
Patient Characteristics ◽  
Cancer Management ◽  
The Us ◽  
The Usa ◽  
Previously Treated ◽  
Tumor Types ◽  
Video Abstract

Background: In July 2019, bevacizumab-awwb and trastuzumab-anns were marketed in the USA as the first therapeutic oncology biosimilars. We aimed to investigate the initial real-world use of bevacizumab-awwb and trastuzumab-anns for cancer management in US oncology practices. Methods: A retrospective, observational analysis of data from US cancer patients (⩾18 years of age) was carried out to describe the use of bevacizumab-awwb and trastuzumab-anns during the first 12 months following their market entry, using structured data from the Flatiron Health electronic health record-derived database. Results: A total of 2952 and 2997 patients with recorded use of bevacizumab-awwb and trastuzumab-anns, respectively, were included in the analysis. The first use of bevacizumab-awwb and trastuzumab-anns was in a patient with metastatic colorectal cancer (mCRC) within 10 days of market availability and in a patient with early stage breast cancer (eBC) within 4 days, respectively. The use of these biosimilars was observed across all approved cancer indications; 68% of bevacizumab-awwb users were those diagnosed with mCRC and 72% of trastuzumab-anns users were those diagnosed with eBC. Approximately half the patients were previously exposed to reference product (RP) prior to initiation of bevacizumab-awwb or trastuzumab-anns. Among pre-exposed patients, the majority received the biosimilars [bevacizumab-awwb (63–85%) or trastuzumab-anns (75–81%)] within 28 days of the last infusion of the RP. For both biosimilars, no major differences were observed in patient characteristics between RP-naïve and pre-exposed patients. Conclusion: Initial evidence from the first 12 months following market entry suggests rapid clinical adoption of bevacizumab-awwb and trastuzumab-anns across all approved tumor types. Usage of these two biosimilars was observed in both RP-naïve patients and patients who were previously treated with RP, with no distinctive differences in patient characteristics between the two groups. A video abstract is available for this article as part of the Kanjintionline supplemental material.

scholarly journals Regulatory Prototype for Biological Products in the United States

2021 ◽  
pp. 60-72
Author(s):  
G. M. Pavithra ◽  
N. Venugopal
Keyword(s):  
Price Competition ◽  
Generic Drugs ◽  
The United States ◽  
Biological Application ◽  
Biological Products ◽  
License Application ◽  
The Us ◽  
High Degree ◽  
Degree Of Similarity ◽  
Improve Access

Biological products are used for the treatment of many disease, so the biological application submitted for the approval of products are also increasing. The progress of a biosimilarproduct is more difficult and expensive than a small molecule generic product. Biosimilars are not true generic drugs, but demonstrate a high degree of similarity to the reference biological product. In order to improve access to costly biological treatments, a biosimilar pathway in the US was established under the Biologics Price Competition and Innovation Act of 2009. The study highlighted the “Regulatory prospective for the registration of Biological products in US” and a brief description about the development, Manufacturing and approval process of biosimilar products. This article is also focused on the regulatory framework, Biological License Application, Purple book, and Pharmacovigilance of biological products.

scholarly journals Patents vs. Statutory Exclusivities in Biological Pharmaceuticals - Do We Really Need Both?

2017 ◽  
Author(s):  
Yaniv Heled
Keyword(s):  
Affordable Care Act ◽  
Price Competition ◽  
Pharmaceutical Products ◽  
Market Exclusivity ◽  
President Obama ◽  
Biological Products ◽  
New Class ◽  
Patient Protection ◽  
Legal Regimes

On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act (BPCIA) as part of the Patient Protection and Affordable Care Act (also known as the Healthcare Bill). BPCIA sets up a framework for the approval of generic biologics and provides for up to 12.5 years of market exclusivity for FDA approved bio-pharmaceutical products. The exclusivity is intended to run in parallel and in addition to any patents that may apply to such approved bio-pharmaceutical products, which would also grant the developers of these products monopolies in the underlying technologies on which such bio-pharmaceutical products are based. This seeming “double dipping” raises questions regarding the need and justification, if any, for such parallel, double protection of this particular class of biological products. This article seeks to address these questions. Analyzing the fundamentals and underlying assumptions of the legal regimes of patents and statutory exclusivities, this article examines their applicability to the context of bio-pharmaceuticals. Based on the conclusions reached, this article then further examines the proposition that statutory exclusivity regimes could become a blueprint for “patentless” areas of technology, replacing the traditional patent regime with a new class of incentives to invent and invest in the development of new technology.Published: Yaniv Heled, Patents vs. Statutory Exclusivities in Biological Pharmaceuticals - Do We Really Need Both?, 18 Mich. Telecomm. Tech. L. Rev. 419 (2012).

scholarly journals Innovative Space Occupied By Indian Pharmaceutical Industry: Future Prospects

2020 ◽  
Vol 5 (1) ◽  
Keyword(s):  
Pharmaceutical Industry ◽  
Patient Outcomes ◽  
Price Competition ◽  
Patent Protection ◽  
Drug Product ◽  
Profit Margins ◽  
Patent Term ◽  
The Us ◽  
Generic Products ◽  
Indian Pharmaceutical Industry

Through the 1984 Drug Price Competition and Patent Term Restoration Act, the Indian Pharmaceutical Industry has thrived in the US market by selling generic products at competitive rates. However, the traditional and conservative model is no longer sustainable as we head past the “patent cliff”. An innovative business model characterized by the development of “super-generics”, an improved version of an original drug product which has lost patent protection, is the next logical step as it is relatively less time consuming and less expensive compared to the development of a new chemical entity, while affording higher profit margins and potentially, better patient outcomes compared to generics. This presentation will highlight the current space occupied by these super-generics, why the traditional Indian Pharmaceutical Industry should transition to become more innovative as well as the regulatory, infrastructure and personnel requirements that such a transition would entail.

The “Open Government Reform” Movement

2016 ◽  
Vol 47 (2) ◽  
pp. 155-171 ◽  
Author(s):  
Suzanne J. Piotrowski
Keyword(s):  
Action Plan ◽  
Administrative Reform ◽  
Reform Movement ◽  
Open Government ◽  
Government Reform ◽  
Research Needs ◽  
President Obama ◽  
National Action Plan ◽  
Administrative Reforms ◽  
The Us

Open government initiatives, which include not only transparency but also participation and collaboration policies, have become a major administrative reform. As such, these initiatives are gaining cohesiveness in literature. President Obama supported open government through a range of policies including the Open Government Partnership (OGP), a multinational initiative. The OGP requires member organizations to develop open government national action plans, which are used as the basis for my analysis. To frame this paper, I use and expand upon David Heald’s directions and varieties of transparency framework. A content analysis of the 62 commitments in the US Second Open Government National Action Plan was conducted. The analysis provides two findings of note: First, the traditional view of transparency was indeed the most prevalent in the policies proposed. In that respect, not much has changed, even with the OGP’s emphasis on a range of approaches. Second, openness among and between agencies played a larger than expected role. While the OGP pushed an array of administrative reforms, the initiative had limited impact on the type of policies that were proposed and enacted. In sum, the OGP is an administrative reform that was launched with great fanfare, but limited influence in the US context. More research needs to be conducted to determine if the “open government reform” movement as a whole suffers from such problems in implementation.

Indication-Specific Generic Uptake of Imatinib Demonstrates the Impact of Skinny Labeling

2022 ◽  
Author(s):  
Bryan S. Walsh ◽  
Aaron S. Kesselheim ◽  
Ameet Sarpatwari ◽  
Benjamin N. Rome
Keyword(s):  
Patent Protection ◽  
Cross Sectional Study ◽  
Myelogenous Leukemia ◽  
Brand Name ◽  
Generic Competition ◽  
Cross Sectional ◽  
The Us ◽  
Lower Drug ◽  
The Impact ◽  
Brand Name Drugs

PURPOSE Generic competition can be delayed if brand-name manufacturers obtain additional patents on supplemental uses. The US Food and Drug Administration allows generic drug manufacturers to market versions with skinny labels that exclude patent-protected indications. This study assessed whether use of generic versions of imatinib varied between indications included and excluded from the skinny labels. METHODS In this cross-sectional study, we identified adult patients covered by commercial insurance or Medicare Advantage plans who initiated imatinib from February 2016 (first generic availability) to September 2020. Generic versions were introduced with skinny labels that included indications covering treatment of chronic myelogenous leukemia (CML) but excluded treatment of gastrointestinal stromal tumors (GISTs) because of remaining patent protections. Logistic regression was used to determine whether use of generic versus brand-name imatinib differed between patients with a diagnosis of CML or GIST, adjusting for demographics, insurance type, prior use of brand-name drugs, and calendar month. RESULTS Among 2,000 initiators, 934 (47%) had CML and 686 (34%) had GIST. Within 3 years after generics entered the market, more than 90% of initiators in both groups used generic imatinib. Initiation of generic imatinib was slightly lower among patients with GIST than among patients with CML (85% v 88%; adjusted odds ratio 0.56; 95% CI, 0.39 to 0.80; P ≤ .001). CONCLUSION Generic versions of imatinib were dispensed frequently for indications both included (CML) and excluded (GIST) from the skinny labeling, although patients with GIST were slightly less likely to receive a generic version. The skinny labeling pathway allowed generics to enter the market before patent protection for treating patients with GIST expired, facilitating lower drug prices.

scholarly journals President Obama, poverty, and the scope and limits of social policy change

2019 ◽  
Vol 35 (1) ◽  
pp. 96-111 ◽  
Author(s):  
Alex Waddan
Keyword(s):  
Social Policy ◽  
Policy Change ◽  
Economic Conditions ◽  
Medicaid Program ◽  
President Obama ◽  
Policy Initiatives ◽  
The Poor ◽  
Poverty Measures ◽  
The Us ◽  
The U.S

AbstractThere has been a growing discussion in recent years about rising inequality in the U.S. Yet, this discourse, in focusing on the fortunes of the top 1%, distracted attention from the design of policy initiatives aimed at improving socio-economic conditions for the poor. This paper examines the development of anti-poverty politics and policy in the US during the Obama era. It analyses how effective the strategies and programmes adopted were and asks how they fit with models of policy change. The paper illustrates that the Obama administration did adopt an array of anti-poverty measures in the stimulus bill, but these built on existing programmes rather than create new ones and much of the effort was stymied by institutional obstacles. The expansion of the Medicaid program, which was part of the ACA, was also muted by institutional opposition, but it was a more path breaking reform than is often appreciated.

scholarly journals The Static-Dynamic Efficiency Trade-off in the US Rail Freight Industry: Assessment of an Open Access Policy

2018 ◽  
Vol 17 (4) ◽  
pp. 267-301
Author(s):  
Daniel Coublucq ◽  
Marc Ivaldi ◽  
Gerard McCullough
Keyword(s):  
Open Access ◽  
Price Competition ◽  
Structural Model ◽  
Consumer Welfare ◽  
Investment Behavior ◽  
Investment Incentives ◽  
Dynamic Efficiency ◽  
Static Efficiency ◽  
The Us ◽  
Network Quality

Abstract Considering the US railroad industry, which is characterized by seven integrated firms that provide freight services on tracks they own and maintain, this paper provides a structural model that allows to evaluate the potential effects of opening the rail network to new firms on prices and investment incentives. In particular, we propose a framework for analyzing the tension between static efficiency (pricing behavior) and dynamic efficiency (investment behavior). The investment behavior is rendered endogenous by means of a dynamic model where the current investment depends on the expected future profits. We then use a forward simulation procedure to analyze the effect of an open-access market structure where a new firm uses the network of one of the biggest railroad firm. Under a simple access charge equaled to the marginal cost of access, investment in network infrastructure decreases by 10% per year, leading to a significant decrease in network quality over time. Under this setting, despite the increase of price competition, the decrease in network quality leads to a fall in consumer welfare. Other types of (more evolved) access charges might even allow to relax the tension between static efficiency and dynamic efficiency, allowing more price competition while preserving investment incentives. This topic deserves further research and is beyond the scope of this paper.

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