Strategy analysis

Biosimilars Portfolio and Pipeline Trends, 2016

Biosimilars are expected to drive significant cost savings for healthcare systems, yet there are many considerations that will affect the success of biosimilars, ranging from clinical development, regulatory approval, and ongoing legal disputes around patents. In the US, this is still a seminal period, and for that reason the potential effects of biosimilars in terms of levels of competition are still too early to gauge. Still, European experience with biosimilars may give an indication as to how market dynamics will play out and the degree to which biosimilar sponsors may discount their biosimilars in the US.

November 23, 2016

Biosimilars Market Access in the US

This strategy report focuses Biosimilars Market Access in the US including the need for biosimilars, regulatory pathways, substitution and naming policy, legal issues, pricing, reimbursement, and market access.

October 23, 2015

Biosimilars Market Access in the U.S.

The route to a formal US regulatory pathway for biosimilar approval was established with the creation of the Biologics Price Competition and Innovation Act of 2010. However, it took five more years for the first biosimilar to be launched in the US through this pathway, namely Zarxio.

March 13, 2017

Biosimilars Market Access in the EU

Biosimilars have been available in Europe for over a decade, and have offered the opportunity to vastly reduce the cost of treatment for a large number of biologic agents.

January 19, 2018

Biosimilars Market Access in Psoriatic Arthritis

Tumor necrosis factor (TNF)-alpha inhibitors Enbrel, Humira, and Remicade have long held dominant positions in the psoriatic arthritis market. These market leaders, however, face patent expirations and consequent biosimilar launches.

March 6, 2017

Biosimilars Market Access in Psoriasis

Tumor necrosis factor (TNF)-alpha inhibitors Enbrel, Humira, and Remicade have long held dominant positions in the psoriasis market; however, these market leaders face patent expirations and consequent biosimilar launches

March 6, 2017

Biosimilars in the US and Europe

Biosimilars have been available in Europe for over a decade, and have offered the opportunity to vastly reduce the cost of treatment for a large number of biologic agents.

June 25, 2019

Biosimilars in Emerging Markets

Follow-on biologics have been embraced enthusiastically in most emerging markets, where they promise to deliver much-needed improvements in access to a generation of products that remains beyond the reach of many patients.

April 20, 2017

Biosimilars and Reimbursement KOL Interview

Topics: Biosimilars and Reimbursement

Physician Information

Specialty: Specialty Pharmaceuticals

Location: Alexandria, VA

July 31, 2015

Biosimilar Insulin Market Access

Biosimilar competition is providing payers with opportunities to contain costs in a category that accounts for a significant proportion of total drug expenditure. The launch of the biosimilar insulin Basaglar is a threat to the insulin-based product market, which includes long-time reference product Lantus as well as newer entrants Toujeo and Tresiba. More aggressive payers are excluding branded insulin products in favor of the less expensive biosimilar, forcing switches in existing patient populations. As such, manufacturers of branded insulin products will need to offer deeper discounts to remain on payers’ formularies and contracts.

June 19, 2017

Biosimilar Commercial Strategies and Tactics

The challenges faced by biosimilar developers are not unlike those confronting their branded counterparts. First, companies must develop high-quality biosimilars and obtain regulatory approval. Next, they must then navigate the vast array of commercial nuances that exist at the national level in order for their products to be used in the clinical setting.

May 14, 2019

Biomedtracker Q3 2017 Outlook Report

In this report, we cover catalysts from 21 drugs expected to occur in Q3 2017. For each drug, the likelihood of Phase/PDUFA review success and overall Likelihood of Approval (LOA) given their particular phase, drug class, and disease group are provided.

August 2, 2017

Biomedtracker Entresto Pulse

Uptake of Entresto (NVS) in the US has been slow following approval in July 2015. Part of that is due to the time it has taken to secure insurance coverage, but physicians have complained about other insurance barriers, as well, and there are also clinical factors that could play a role.

May 11, 2016

Biomedtracker Diabetic Nephropathy/Diabetic Kidney Disease KOL Interview

Biomedtracker interviewed a nephrologist based in the US Midwest to determine his views on the drugs in development for diabetic nephropathy/diabetic kidney disease.

May 13, 2016