Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 20 June 2016 | By Zachary Brennan
For those tracking the contentious debate over drug and biologic price hikes in the US, an IMS Health report released on Monday offers the latest evidence yet that a robust biosimilars market can not only lower prices across drug classes but also increase patient uptake of such treatments.
“The increased competition affects not just the price for the directly comparable product but also has an effect on the price of the whole product class,” the report says. “In countries which used to have low usage/availability in the classes, the price reductions seem to have a significant impact on the increased access.”
The report follows the release of a separate report in March noting that biosimilars could save health systems across Europe and the US as much as $110 billion through 2020.
A biosimilar medicinal product is a biologic medicine similar to another biologic medicine that has already been authorized for use in the EU.
Since 2006, the EU has seen the approval of 20 such biosimilars (see below), while only two have been approved in the US, including Celltrion and Pfizer’s Inflectra (infliximab-dyyb), which is biosimilar to Janssen Biotech’s Remicade (infliximab) and Sandoz' Zarxio (filgrastim-sndz), which is biosimilar to Amgen's Neupogen (filgrastim).
The EU is also out-pacing the US in terms of which biosimilars are under review:
The new report tracks the uptake and price reductions across four classes of treatments – Epoteins (EPOs), injectables that can treat anemia, granulocyte-colony stimulating factor (G-CSF), which can be used to accelerate recovery from neutropenia linked to chemotherapy treatment for cancer patients, human growth hormone (HGH), which stimulates growth; and anti-tumor necrosis factor (anti-TNF) drugs that are used to treat inflammatory conditions – that have seen varying levels of biosimilar approvals.
“For the 4 classes we can see the same pattern; high savings can be achieved even if biosimilar uptake is low,” the report says.
And these price reductions are not just seen for the directly comparable products but for the entire product class.
However, like in the US, which has been careful to approve biosimilars only for indications that prove viable from clinical trials, the report notes the differences in approved indications are relatively small for HGH and G-CSF treatments, somewhat larger for EPOs and the largest for Anti-TNF, which has only seen the launch in February of the first entanercept biosimilar (known as Benepali) referencing Enbrel and which has just been launched by Samsung Bioepis (joint venture between Samsung and Biogen) in Norway, Germany, UK and Sweden.
“As a result, different products are used for different indications, which impact the patients for which they compete in the class. This is most obvious in Anti-TNF. Frequency of administration and mode of administration also impact the competition within a class,” the report says.
An updated question and answer document on biosimilars is expected to be released by the end of June from the European Commission, according to a presentation of the IMS report in Brussels at a stakeholder conference.
The impact on biosimilar competition on price, volume and market share - updated version 2016
Tags: biosimilars, EU uptake of biosimilar medicinal products, IMS Health, EPO, Anti-TNF, Humira, Enbrel, Remicade