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

$499.00

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

Breast Cancer Pulse Survey

Drugs and drug candidates discussed:

palbociclib, neratinib, Herceptin, Perjeta, Kadcyla, Tykerb, Afinitor

April 23, 2014

Catch Up On CAR-T

$699.00

Sale!

With the approval of the first CAR-T therapies – Novartis’ Kymriah and Gilead/Kite’s Yescarta – what had been the promise of cutting-edge science is now reality.

November 24, 2017

CER, HEOR, and Value-Based Frameworks in the US

It is no secret that Americans spend heavily on healthcare – in 2013, US healthcare expenditure totaled nearly $3bn ($9,255 per person) and accounted for 17.4% of gross domestic product.

October 17, 2016

China Regulatory Update

China has recently completed its 2009–11 healthcare reform. The reform has come at a high cost: although the Ministry of Health intended to invest CNY850bn ($135bn) in the plan, total investment has now exceeded CNY1,100bn ($175bn).

November 4, 2016

Chronic Heart Failure Pricing, Reimbursement, and Access

Payers were originally extremely worried about the potential cost burden of Entresto, however, the level of concern surrounding the drug is currently moderate as physician uptake has been lower than expected.

April 13, 2018

Chronic Lymphocytic Leukemia (CLL) KOL Interview – Germany

A Germany-based key opinion leader (KOL) gives insights into prescribing habits, key marketed brands, and late-phase pipeline therapies for CLL. Pipeline therapies discussed include Brukinsa, U2 regimen, non-covalent BTK inhibitors, and CD19-directed CAR-T therapy.

Chronic Lymphocytic Leukemia (CLL) KOL Interview – Italy

An Italy-based key opinion leader (KOL) provides insights into prescribing habits, key marketed brands, and late-phase pipeline therapies for CLL. Key pipeline assets highlighted include non-covalent BTK inhibitors, Brukinsa, and CD19-directed CAR-T therapies.

Chronic Lymphocytic Leukemia (CLL) KOL Interview – US

A US-based key opinion leader (KOL) provides insights into prescribing habits, key marketed brands, and late-phase pipeline therapies for CLL. Key pipeline assets highlighted include the CAR-T therapy Breyanzi, reversible BTK inhibitors MK-1026 and pirtobrutinib, and the PI3K inhibitor TG-1303.

October 1, 2020

Chronic Lymphocytic Leukemia (CLL) KOL Interview – US, South #1

A US-based key opinion leader (KOL) gives insights into prescribing habits, key marketed brands, and late-phase pipeline therapies for CLL. Pipeline therapies discussed include Brukinsa, U2 regimen, non-covalent BTK inhibitors, and CD19-directed CAR-T therapy.

Chronic Lymphocytic Leukemia (CLL) KOL Interview – US, South #2

A US-based key opinion leader (KOL) gives insights into prescribing habits, key marketed brands, and late-phase pipeline therapies for CLL. Pipeline therapies discussed include Brukinsa, U2 regimen, non-covalent BTK inhibitors, and CD19-directed CAR-T therapy.

Chronic Migraine Survey

Datamonitor conducted a 5-question survey of 26 United States and 25 European (based in France, Germany, Italy, Spain and United Kingdom) neurologists involved in pain management to gauge current prescribing practices in prophylactic treatment of chronic migraine and potential future use of the calcitonin gene-related peptide (CGRP) receptor targeting monoclonal antibody (mAb) AMG 334 (AMGN) and CGRP targeting mAbs ALD403 (ALDR) and TEV-48125 (TEVA).

March 9, 2017

Chronic Myeloid Leukemia (CML) KOL Interview – UK

This interview with a UK-based key opinion leader (KOL) provides insights into prescribing habits, key marketed brands, and late-phase pipeline therapies for chronic myeloid leukemia. Disease stratifications by phase, as well as unmet needs, are also discussed. Key pipeline assets highlighted include asciminib, SCO-088, and ASTX030.

August 5, 2021

Chronic Myeloid Leukemia (CML) KOL Interview – US, Midwest

This interview with a US-based key opinion leader (KOL) provides insights into prescribing habits, key marketed brands, and late-phase pipeline therapies for chronic myeloid leukemia. Disease stratifications by phase, as well as unmet needs, are also discussed. Key pipeline assets highlighted include asciminib, SCO-088, and ASTX030.

August 5, 2021

Chronic Neuropathic Pain KOL Survey

Biomedtracker performed a 5-question survey of 30 United States neurologists who currently treat patients with chronic neuropathic pain and prescribe opioids to at least some of their patients with chronic neuropathic pain to gauge current use of adjuvants (TCAs, anti-convulsants, SNRIs, SSRIs, and NMDA receptor antagonists) and potential future use of cebranopadol and raxatrigine to treat chronic neuropathic pain.

March 9, 2017

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Chronic Obstructive Pulmonary Disease (COPD): Market Access Pricing & Reimbursement

$7,000.00

Long-acting beta 2 agonist/long-acting muscarinic antagonist (LABA/LAMA) combination inhalers have been gaining traction due to an expanding evidence base for their wider use, and competitive pricing.

October 17, 2016