Tag: M710

Who Are the Key Aflibercept Biosimilar Players to Watch?

One of two biologics injected intravitreally to treat forms of macular degeneration, edema, or retinopathy, Eylea® (aflibercept) was first approved by the US Food and Drug Administration (FDA) on November 18, 2011. Originally approved as a single-dose vial, its manufacturer, Regeneron, received FDA approval of a prefilled syringe in December 2019. We covered the potential biosimilar competitors for the second product, Lucentis® (ranibizumab), in January 2020.

Eylea has significantly greater sales (and growing) than Lucentis. Regeneron reported Q4 2019 US revenues for the innovator product Eylea at $1.22 billion, which represented a 14% increase over the same quarter of 2018. Total US sales for 2019 were $4.64 billion. In its most recently reported quarter (Q2 2020), sales slipped to $1.114 billion, but this was likely attributable to the COVID-19 outbreak discouraging physician office visits. In comparison, Lucentis sales are roughly a quarter of this figure.

Aflibercept belongs to the class of vascular endothelial growth factor agents, and there are two forms currently prescribed. Eylea is indicated for ophthalmologic uses only. Zaltrap® (also known as ziv-aflibercept) was approved for use as an intravenous infusion for oncology patients to address specific cancer mutations. Regeneron and partner Sanofi Genzyme own the rights to Zaltrap.

Several aflibercept biosimilar candidates are in development, hoping to market after the 2020 US patent expiration. The following is a summary of the publicly disclosed players.   

AFLIBERCEPT BIOSIMILAR CANDIDATES

Company NameDrug NamePossible FDA Submission Dates
MylanMYL-1701PQ1-Q2 2021
Samsung BioepisSB15Q1 2022
AmgenABP 938Q1-Q2 2022
FormyconFYB203Q3–Q4 2022
AlteogenALT-L92023
Coherus BiosciencesCHS-20202024

Mylan. MYL-1701P (also referred to as M710, as part of a partnership with Momenta Pharmaceuticals) is perhaps the aflibercept biosimilar that is furthest along in the development process. It is currently the subject of a 324-patient phase 3 trial. The patients in this study, which started in 2018 and is scheduled to be completed in December 2020, have diabetes-related macular edema. Earlier this month, Momenta was acquired by Johnson & Johnson, and M710 was the sole biosimilar remaining in its portfolio. Mylan is to handle development and commercialization.  Mylan believes that it will file a 351(k) submission by early 2021, which could mean an FDA decision in early Q1 2022.

Samsung Bioepis. SB15 is an aflibercept biosimilar candidate that began a phase 3 trial on June 23, 2020. The recruitment objective is 446 participants with neovascular age-related macular degeneration, with a scheduled completion date of February 2022 (primary completion date of March 2021). Samsung completed its phase 3 trial of its Lucentis biosimilar SB11 in December 2019, which is interesting, because of the direct competition between the Lucentis and Eylea brands.

Amgen. ABP 938 is Amgen’s aflibercept biosimilar candidate. A phase 3 trial of this agent began in June 2020, comparing ABP 938 with US-licensed Eylea in 566 patients with neovascular age-related macular degeneration. The study is scheduled to conclude in July 2022, with primary results reported in September 2021.

Alteogen We first reported on theSouth Korean company Alteogen in January 2018, when it had completed preclinical testing on the investigational aflibercept biosimilar ALT-L9. The phase I trial for this aflibercept biosimilar was slated to begin October 2019 in patients with patients with neovascular age-related macular degeneration. The completion date is December 2020.

Formycon. Bioeq GmbH is responsible for managing Formycon’s pharmaceutical development program for its aflibercept biosimilar FYB203. Bioeq began a phase 3 trial on July 23, 2020 to compare FYB203 to Eylea in 400 patients with neovascular, age-related macular degeneration. With a primary completion date of August 2021, this should enable Formycon to file an application with the EMA in 2025 and/or the FDA sometime in 2022 and potential US introduction in 2023.

Coherus Biosciences. Coherus BioSciences, the maker of the pegfilgrastim biosimilar Udenyca®, is still in the preclinical development stage with its aflibercept biosimilar candidate CHS-2020. According to Coherus, clinical trials for this biosimilar is slated to begin in 2021. Based on this timeline, FDA submission may not occur until the 2024 timeframe, which could make Coherus one of the late arrivals to market.

An FDA Filing for Momenta’s Adalimumab Biosimilar Coming Soon?

Momenta seems to be in final preparations for its first 351(k) filing to the Food and Drug Administration (FDA). In its recent investor conference, the company disclosed that it is ready to send M923, its adalimumab biosimilar, to the agency for approval.

Momenta's Adalimumab Biosimilar
Craig Wheeler, CEO of Momenta Pharmaceuticals

Despite this promising news, Momenta is facing strong headwinds. Even if it gains approval, Momenta expects that the US launch of the adalimumab biosimilar will not occur until 2023, owing to pending patent issues with Abbvie’s Humira®. The company does not yet have a marketing partner for this agent, though there appears to be plenty of time.

In addition, Momenta received a setback in November 2017 on another looming biosimilar candidate, when its biosimilar version of abatacept failed its phase 1 trial. Apparently, its M834 produced pharmacokinetic results that differed from the originator Orencia® in this early clinical study. Momenta is still studying the data and trying to come to grips with the surprising findings.

The company is also set to begin “pivotal” clinical trials on its other drug candidate M710, a biosimilar to aflibercept. The originator product is Eylea®, and it is indicated to treat wet age-related macular degeneration.

Momenta’s partnership with Mylan is moving forward with preclinical work on four other nonspecified biosimilars, according to the company. But all of this development costs money, and Momenta has acknowledged that it may need to raise cash for future development.

Momenta received approval in January for a generic form of the multiple sclerosis drug Copaxone® (glatiramer acetate). The approval of this agent, produced in partnership with Sandoz, had been delayed because of manufacturing issues. The company recognizes that the entry of Mylan (ironically) into this market may hinder its financial outlook.

As a result of these developments, Momenta stated it would entertain a sale of its adalimumab biosimilar “or other assets.”

 

The Patent Games: Another Sequel Underway

Roche/Genentech has filed suit in Delaware, citing the alleged violation of 37 patents by Amgen in its intent to market its biosimilar version of Herceptin®.  

The litigation was filed in response to Amgen’s stated intention of launching their product in October 2018, based on a May approval. Unfortunately, the Food and Drug Administration decided not to approve Amgen and Allergan’s initial 351(k) application in early June.

Roche has been engaged with Pfizer and the team of Celltrion and Teva on their trastuzumab biosimilars as well.