Eye on Pharma: Formycon Aflibercept Data; Sandoz CHMP Nod; Henlius Daratumumab Study

Recently, Formycon shared positive data on its aflibercept biosimilar; Sandoz received a thumbs up from the European Union’s Committee for Medicinal Products for Human Use (CHMP) for an adalimumab biosimilar; and Shanghai Henlius Biotech began a phase 1 study for its daratumumab biosimilar candidate.

Formycon Shares Aflibercept Biosimilar Data

Formycon, a Munich, Germany-based company, published preliminary safety and efficacy data from the phase 3 MAGELLAN-AMD clinical trial assessing the company’s aflibercept biosimilar (FYB203) in comparison to the reference product (Eylea).

The results from the randomized, double-blind, multi-center study met the primary efficacy endpoint, demonstrating biosimilarity between the 2 products in patients with neovascular age-related macular degeneration (wet AMD). Additionally, no differences in safety or immunogenicity were observed between the products.

Formycon’s announcement follows the UK, EU, and US approvals of FYB201, a ranibizumab biosimilar that is also used to treat wet AMD. The company said that an estimated 77 million Europeans will be affected by AMD by 2050.

“We are delighted that our second project in the field of ophthalmology was able to impress in the clinical phase III MAGELLAN-AMD study. Given the extensive experience from FYB201, we are confident that we will also be able to make a high-quality and cost-effective biosimilar available with FYB203, thereby further expanding our strong position in the field of biosimilar development,” commented Andreas Seidl, PhD, chief scientific officer at Formycon, in a statement.

Sandoz Receives Thumbs Up for Hyrimoz

The European Medicines Agency’s CHMP granted Sandoz with a positive opinion for a citrate-free, high-concentration formulation (HCF) of its adalimumab biosimilar, Hyrimoz, bringing the product one step closer to regulatory approval across the European Union.

If authorized by the European Commission, Hyrimoz HCF will be used to treat all indications of the reference product (Humira), including rheumatoid arthritis, Crohn disease, ulcerative colitis, plaque psoriasis, and uveitis. The high-concentration formulation will allow for patients to go longer periods of time between doses and the citrate-free feature will reduce injection site pain for patients.

“For people who live with a chronic condition, seemingly small adjustments to formulations can have a significant improvement on quality of life…. Today’s positive opinion from the CHMP brings us closer to providing a treatment choice to patients that offers increased convenience and a reduction in injection volume,” said Florian Bieber, global head of biopharmaceuticals development at Sandoz, in a statement.

The CHMP’s opinion was based on clinical data from a phase 1 pharmacokinetics study comparing the original Hyrimoz (50 mg/mL) and Hyrimoz HCF (100 mg/mL). The original Hyrimoz was granted EU marketing authorization in July 2018.

The news comes as Sandoz’ biologics license application for its proposed denosumab biosimilar (GP2411) was accepted for review by the FDA.

Henlius Begins Testing Daratumumab Biosimilar

Shanghai Henlius Biotech announced that it has begun dosing healthy participants with its daratumumab biosimilar (HLX15) as part of a phase 1 clinical study assessing the pharmacokinetic, tolerability, and safety profiles of the drug in comparison to the reference product (Darzalex).

HLX15 is a recombinant anti-CD38 monoclonal antibody that, if approved, will be used to treat patients with multiple myeloma (MM), the second most common hematological malignancy in the world and often present in senior populations. CD38 plays a role in metabolism regulation and is often expressed in plasma cells, lymphoid cells, and myeloid cells.

The study will have 2 parts. The phase 1a study will assess the drug in 24 participants, who will receive a single intravenous injection of the biosimilar or the China-sourced reference product and be followed for up to 1 week for safety observation. The phase 1b study will include 204 participants, who will also receive 1 intravenous injection of the biosimilar, the China-sourced reference product, or the US-sourced reference product.