Tag: EMA

A Profile on Lesser-Known Player in the Biosimilar Space: Formycon AG

On occasion, we profile some biosimilar manufacturers about whom our readers may not be as familiar as the large players like Sandoz, Amgen, and Pfizer. This generally refers to companies that have products that are in earlier-stage research or those who simply have not been in the news as often as their colleagues. In this updated post, we highlight a German company, Formycon AG, which has eyes on the US marketplace.

Formycon acquired Scil Technology GmbH in 2012, and hired a new CEO the following year. Carsten Brockmeyer, PhD, has extensive experience in the biosimilar field, previously helping Hexal Biotech to develop EPO and filgrastim biosimilars for the European market.

Why you may be hearing more about this company: Formycon has two principal biosimilar targets, ranibizumab and ustekinumab. The company disclosed that “it successfully completed a Type IV pre-submission meeting with the US Food and Drug Administration (FDA) in December 2018 and clarified other pivotal issues. The filing with the FDA for the approval of FYB201 is expected at the beginning of the fourth quarter of this year.” A filing for the European Medicines Agency is planned for 2020. A phase 3 clinical trial of this agent was completed in June 2018. In the development of this agent, Formycon partnered with Bioeq GmbH, but it is unclear whether a marketing partner exists for a possible US launch.

The patent for ustekinumab (Stelara®) expires in 2023 (US) and 2024 (Europe). It is partnered with Aristo Pharma GmbH on the manufacture and testing of this interleukin 12/23 inhibitor (also known as FYB 202).

Formycon is in the early stages of developing a phase 3 trial for its biosimilar version of Eylea® (aflibercept or FYB 203), the next generation of macular degeneration treatment. It is partnered with Santo Holding GmbH on the development of aflibercept.

In other biosimilar news… Amgen decided to pull its EMA application for its infliximab biosimilar, likely due to market competition. The company has not taken similar action with regard to an FDA application for the same product, ABP 710. Considering that neither Samsung Bioepis or Pfizer failed to gain traction in the US marketplace for infliximab, Amgen must think that some biosimilar infliximab marketshare growth in the US is still possible.

Up to 5 Biosimilar Horses in the Race for Adalimumab in Europe: Heading for the Starting Gate

A long-sought dream in the United States will be a welcome reality in Europe this October: a stampede for Abbvie’s marketshare with adalimumab biosimilars and the savings that go with it.

Four or possibly five manufacturers will be lined up in the starting gate. Fujifilm Kyowa Kirin Biologics and its marketing partner Mylan have not yet received approval from the European Medicines Agency (EMA), but they do have a positive opinion from the Committee on Human Medicinal Products. They expect to hear a final decision from the EMA by October and hope to market it that same month, joining the other adalimumab biosimilar drugmakers.

Those who already have approval to race include:

Manufacturer/Marketing  Partner

Molecule Designation

Brand Name
Samsung Bioepis/Merck
SB5
Imraldi
Boehringer Ingelheim
BI 695501
Cyltezo
Amgen
ABP 501
Amgevita
Sandoz
GP2017
Hyrimoz
Adapted from: http://www.gabionline.net/Biosimilars/General/Biosimilars-of-adalimumab.

Several other manufacturers are also in the running, but will be late entries. They have completed phase III studies but their biosimilar adalimumab applications are not yet filed: Coherus, Pfizer, Fresenius, and Momenta.

adalimumab biosimilarsOn October 16, Abbvie’s Humira® patent expires and the starting gate should open. We’ve not seen anything similar in the US biosimilar market. Even when Abbvie’s patents expire in 2022 and agreements go into effect, this will be more of a staggered start, with Amgen having first crack at the market in January 2023 followed by Samsung Bioepis in June of that year. That is, unless another biosimilar manufacturer refuses to sign a licensing agreement with Abbvie and launches at risk earlier.

In any case, the savings seen in the EU should be immediate and if competition is not hindered, adalimumab biosimilar prices will be slashed. It will be interesting to see how this situation plays out, with one of the world’s biologic sales leaders.

It will certainly leave American payers dreaming about what could be, but will not be, for several years at least.

Amgen/Allergan Score Positive EMA Evaluation, but Launch Will Be Delayed

A couple of noteworthy pieces of news have emerged from across the pond on the biosimilar front. The first involves progress for Amgen’s application for its bevacizumab biosimilar at the European Medicines Agency (EMA). Its drug evaluation arm, the Committee for Medicinal Products for Human Use, recommended approval of the biosimilar on November 9.

Assuming EMA final approval is received, however, Amgen and Allergan’s cancer treatment agent will not be marketed any time soon. The principal European patent is not set to expire until 2022.

Image result for avastin biosimilarIn the US, Mvasi™ was approved by the Food and Drug Administration in September, but its launch is similarly delayed by patent litigation. The main US patents should expire in 2019 (Roche claims to hold 27 enforceable patents). Amgen had filed suit October 6 challenging the validity of the patents in question, but this case may not be heard until late 2018. Amgen has the option of launching “at-risk,” but it has not indicated that it will go this route. Otherwise, the earliest launch may be sometime in 2019.

Several other potential bevacizumab makers have already challenged the patents, according to other reports. These include Boehringer Ingelheim, Celltrion, Pfizer, and Samsung Bioepis.

In other related news…An announcement will be made on November 20 regarding where the EMA will relocate its headquarters as a result of the Brexit. The Agency will need to complete its move by March 31, 2019, when Britain’s divorce from the European Union is finalized.