| Title |
Biosimilars in the United States: Emerging Issues in Litigation
|
|---|---|
| Published in |
BioDrugs, April 2017
|
| DOI | 10.1007/s40259-017-0216-7 |
| Pubmed ID | |
| Authors |
Alice Yuen-Ting Wong, Martha M. Rumore, Albert Wai-Kit Chan |
| Abstract |
Many first-generation biologics will lose their patent protection by 2020. The biosimilars market is not only attractive but also competitive and tough. The United States (US) is the world's largest pharmaceutical market and is critical to the success of most drugs. However, unclear regulatory requirements and confusing patent resolution procedures create hurdles to market entry of biosimilars. Trade secret exposure and scant exclusivity and adoption also limit the market access of biosimilars. Both biologics and biosimilar developers should closely follow the regulatory and litigation landscape to successfully navigate through the challenges. Focusing on the US landscape, this article provides a brief review of the regulatory framework for biosimilar products, market exclusivities, and patent issues under the Biologics Price Control and Innovation Act (BPCIA), analyzes emerging issues in the biosimilar litigation landscape, and provides recommendations for companies entering the biosimilars market. |
Mendeley readers
The data shown below were compiled from readership statistics for 36 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 36 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 7 | 19% |
| Student > Ph. D. Student | 4 | 11% |
| Researcher | 3 | 8% |
| Student > Bachelor | 2 | 6% |
| Other | 2 | 6% |
| Other | 3 | 8% |
| Unknown | 15 | 42% |
| Readers by discipline | Count | As % |
|---|---|---|
| Pharmacology, Toxicology and Pharmaceutical Science | 6 | 17% |
| Biochemistry, Genetics and Molecular Biology | 4 | 11% |
| Medicine and Dentistry | 3 | 8% |
| Economics, Econometrics and Finance | 2 | 6% |
| Unspecified | 1 | 3% |
| Other | 5 | 14% |
| Unknown | 15 | 42% |
Attention Score in Context
This research output has an Altmetric Attention Score of 4. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 01 March 2021.
All research outputs
#7,530,190
of 23,642,687 outputs
Outputs from BioDrugs
#274
of 683 outputs
Outputs of similar age
#116,675
of 311,387 outputs
Outputs of similar age from BioDrugs
#7
of 11 outputs
Altmetric has tracked 23,642,687 research outputs across all sources so far. This one has received more attention than most of these and is in the 67th percentile.
So far Altmetric has tracked 683 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 6.6. This one has gotten more attention than average, scoring higher than 59% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 311,387 tracked outputs that were published within six weeks on either side of this one in any source. This one has gotten more attention than average, scoring higher than 61% of its contemporaries.
We're also able to compare this research output to 11 others from the same source and published within six weeks on either side of this one. This one is in the 45th percentile – i.e., 45% of its contemporaries scored the same or lower than it.