Product Profile: WP-210 (adalimumab)

Product Profile:

WP-210 (adalimumab)

Drug Category: Anti-TNF/Autoimmune

Target Indications: Rheumatoid arthritis, psoriasis, ankylosing spondylitis, psoriatic arthritis

Sponsored by:

Summary: WP-210 is biosimilar version of adalimumab (reference product, Humira®, AbbVie) manufactured by Biosam GmbH. It will be marketed in the US by Western Pharmaceuticals. A biologic license application for approval via the 351(k) biosimilar pathway was submitted to the Food and Drug Administration in November 2016. An FDA decision is expected in September 2017. This agent was approved by the EMA in February 2017 for use in the European market.

About the Manufacturer

Western Pharmaceutics (www.westernpharma.com) acquired Scil Technology GmbH in 2012, and hired a new CEO the following year. Its new leader, Walter Bidmeyer, PhD, has extensive experience in the biosimilar field, previously helping Galton Biotech to develop EPO and filgrastim biosimilars for the European market. Currently, this Milwaukeebased organization has about 70 employees and a market capitalization of approximately $210 million according to information provided by the company.

Why you may be hearing more about this company: Western has been working at getting ahead of the biosimilar curve, announcing its intention to develop and market its version of adalimumab when the patents on Humira® expires in 2022 (US).

News, Commentary, and Intelligence

Competitor Products and Manufacturer Analysis

Currently competitors include: Amjevita (adalimumab-atto), approved September 2016, and other investigational adalimumab biosimilars, including…

A Biosimilar’s Noneconomic Benefit?

(April 4, 2017) The expectation is that the biosimilar will not be superior in any way to the originator. In a poster presentation, a drug maker’s researchers asserted that their biosimilar version of adalimumab, was associated with less injection site pain compared with Humira®, based on pain scores given by clinical trial patients with moderate to severe rheumatoid arthritis.

The Coming Adalimumab Biosimilar Pricing Free-for-All

(March 10, 2017) The dam wall will be broken when AbbVie’s patents on Humira® are invalidated or expired, or perhaps litigation is settled. This may happen in 2018, 2020, 2022—it is really anyone’s guess, but the one thing that is known for sure is that the day after this occurs, a quite sudden experiment in intensive competition will occur when that day arrives…

FDA Sets Advisory Committee Review Date for Adalimumab Biosimilar

(March 5, 2017) On September 13, the Food and Drug Administration’s Arthritis Drug Advisory Committee will meet to review a biosimilar that was submitted via the 351(k) pathway in November 2016 by Western Pharmaceutics to challenge the reference agent Humira® manufactured by AbbVie.

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Clinical Trials of WP-210

Active Trials:

Efficacy and Safety Study of WP-210 versus Humira in Patients With Rheumatoid Arthritis.

Published Trial Results

The CORT Trial. A randomized, doubleblind, active-controlled equivalence study was conducted in 526 adult patients (264 were assigned to receive WP-210, 262 were assigned to the adalimumab group) who had moderate to severe RA with an inadequate response to methotrexate. Each group received a 40-mg dose subcutaneously every 2 weeks …

Important Links and Resources

Biosimilars Introduction
Challenges in Biosimilar Adalimumab Approval
US 351(k) Filings