Strategy analysis

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 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 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 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 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 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 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

Bladder Cancer KOL Interview – US

A US KOL provides insight into the current treatment landscape for bladder cancer. Critical unmet needs in the bladder cancer market along with future trends are also discussed.

May 31, 2019

Bladder Cancer Pricing, Reimbursement, and Access

Payers are not overly worried about the cost of bladder cancer, due to the relatively small patient population in comparison to other solid tumors.

September 27, 2018

Breakthrough Therapy Designation: Paving the Way for Innovation

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With the passage of the FDA Safety and Innovation Act of 2012 (FDASIA), the Breakthrough Therapy Designation (BTD) was introduced as the newest mechanism to facilitate expedited development and review. Here we provide an overview of the BTD pathway and its evolution over the past three years.

April 23, 2015

Breast Cancer KOL Insight Interview

Physicians are starting to use Perjeta (Roche) as an add-on to Herceptin in the adjuvant setting due to a recent
change in NCCN (National Comprehensive Cancer Network, an alliance of major cancer centers) guidelines.

May 8, 2014

Breast Cancer Pulse #1

We performed a 5-question survey of 22 oncologists in the US to gauge current prescribing practices for breast cancer treatments, with a focus on HR+/HER2- recurrent or metastatic breast cancer. Drugs discussed: •Ibrance (palbociclib, PFE) •Afinitor (everolimus, NVS) •Halaven (eribulin, Eisai) •Abraxane (nab-paclitaxel, CELG) •Doxil (pegylated liposomal doxorubicin, JNJ) •Gemzar (gemcitabine, LLY) •Xeloda (capecitabine, Roche)

October 31, 2016

Breast Cancer Pulse #2

We performed a 5-question survey of 24 oncologists in the US to gauge current prescribing practices for breast cancer treatments, with a focus on HR+/HER2- recurrent or metastatic breast cancer. Drugs and drug candidates discussed: •Neratinib, PBYI •Herceptin (trastuzumab), Roche •Perjeta (pertuzumab), Roche •Kadcyla (trastuzumab-DM1), Roche •Tykerb (lapatinib), GSK

October 31, 2016