Formycon’s completed acquisition of 2 biosimilar assets and start of development for 2 others provide hope for investors as the company announced some expected losses during the first quarter of fiscal year 2022.
In Formycon’s earnings report, the German company revealed that its acquisition of 2 biosimilar candidates, FYB201 and FYB202, has been completed and development of biosimilars FYB208 and FYB209 has commenced.
In April 2022, Formycon announced the acquisition of FYB201 and FYB202 from ATHOS, saying that it would gain the full rights for the commercialization, development, and approval of FYB202, an ustekinumab biosimilar referencing Stelara, and a 50% share of FYB201, a ranibizumab biosimilar referencing Lucentis.
FYB202 will be used to treat plaque psoriasis, psoriatic arthritis, and inflammatory bowel disease and FYB201 will be used in the treatment of patients with ophthalmic conditions, including neovascular (or wet) age-related macular degeneration, macular edema, and diabetic retinopathy. Neither the products that FYB208 and FYB209 reference nor the disease states they will target have been disclosed to the public yet.
“With the acquisition of the 50% stake in FYB201 as well as the full integration of FYB202 into the Formycon Group and the associated increase of our share in future expected revenues, we are in a position to accelerate the expansion of the development pipeline in line with our growth strategy,” said Nicolas Combé, PhD, chief financial officer at Formycon, in a statement.
“The implementation of this strategy is reflected in the initiation of two new biosimilar projects. With the launch of FYB208 and FYB209, we are laying the foundation for a further increase in pipeline valuation and sustainable business growth,” he added.
At the same time, Formycon reported that it experienced some expected losses during the first quarter of fiscal year 2022. As of March 31, 2022, the company amassed €8.2 million in group turnover including other income. Earnings before interest, taxes, depreciation, and amortization dropped by €4.0 million from the previous quarter, about €1.7 million year-over-year, which Formycon said was in line with its expectations.
Formycon forecasted that sales for 2022 will be about €37 million, greater than the amount accumulated the previous year.
The losses were attributed to planned liquidity ratios of the Formycon Group that developed by the end of the first quarter of the year, which included stocks of liquid assets, comprising cash, checks, bank deposits, and services values at €20.1 million. Formycon said that the Formycon Group liquid assets amounted to €24.5 million at the end of the quarter.
During the first 3 months of 2022, Formycon AG, the company’s actual operational unit, had a turnover of €6.5 million, which was down €4.4 million from the 3 months prior and €2.1 million down from the first 3 months of 2021.
BioRationality: Withdrawal of Proposed Terminal Disclaimer Rule Spells Major Setback for Biosimilars
December 10th 2024The United States Patent and Trademark Office (USPTO)’s withdrawal of its proposed terminal disclaimer rule is seen as a setback for biosimilar developers, as it preserves patent prosecution practices that favor originator companies and increases costs for biosimilar competition, according to Sarfaraz K. Niazi, PhD.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Pertuzumab Biosimilar Shows Promise in HER2-Positive Breast Cancer Treatment
December 9th 2024The proposed pertuzumab biosimilar QL1209 demonstrated equivalent efficacy and safety to reference pertuzumab (Perjeta) in neoadjuvant treatment of HER2-positive, ER/PR-negative early or locally advanced breast cancer, offering a cost-effective alternative with comparable clinical outcomes.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Aflibercept Biosimilar MYL-1701P Provides Equivalence in DME Therapy
November 27th 2024The study findings demonstrate that the aflibercept biosimilar MYL-1701P is as effective and safe as the reference aflibercept in treating diabetic macular edema (DME), offering a promising option for reducing treatment costs and improving global access to care for patients with DME.
Ocrelizumab Biosimilar Shows Equivalent Efficacy as Multiple Sclerosis Treatment
November 26th 2024The phase 3 trial (NCT04966338) found that a biosimilar ocrelizumab candidate (Xacrel) was equivalent to Ocrevus in reducing the annualized relapse rate and showed comparable safety and efficacy in treating relapsing multiple sclerosis over 96 weeks.