Polpharma SA

Takeda’s Entyvio generated Y936.1bn ($6.2bn) in the first nine months of 2023, as per Takeda’s Q3 financials. Image Credit: Marian Weyo / Shutterstock. Netherland-based Polpharma Biologics has released topline results from the Phase III trial of its biosimilar candidate PB016, showing that the biosimilar is non-inferior to its reference biologic, Takeda Pharmaceuticals’ Entyvio (vedolizumab). Entyvio is an α4β7 integrin targeting monoclonal antibody that helps in reducing gastrointestinal inflammation. It was approved to treat inflammatory bowel disease (IBD), namely ulcerative colitis (UC) and Crohn’s disease, by the US Food and Drug Administration (FDA) in 2014. The therapy generated Y936.1bn ($6.2bn) in the first nine months of 2023, as per Takeda’s Q3 financials. The Phase III trial evaluated the efficacy, safety and immunogenicity of PB016 in comparison with Entyvio in 120 healthy participants. PB016 was comparable to Entyvio across pharmacokinetic and pharmacodynamic parameters. Furthermore, there were no immunogenicity or safety imbalances between the two therapies. Polpharma is also investigating PB016 in a Phase III trial (NCT05771155) against Entyvio in UC patients. The study is expected to enrol 750 participants and will conclude in September 2025, as per ClinicalTrials.gov . The IBD market is predicted to grow in the next decade, and GlobalData estimates that the Crohn’s and UC markets will be worth approximately $14.9bn and $11.2bn by 2032. The global sales of Entyvio are projected to reach $7.9bn by 2029, as per GlobalData’s market analysis. See Also: Modakafusp alfa by Takeda Pharmaceutical for Metastatic Melanoma: Likelihood of Approval GlobalData is the parent company of Pharmaceutical Technology . Takeda has also invested in sustaining and increasing revenue generated by Entyvio. The company developed a subcutaneous formulation of the monoclonal antibody, which was approved by the US FDA as a maintenance therapy to treat moderately to severely active UC in adults following induction therapy with intravenous Entyvio in September 2023. Another biosimilar developed by Polpharma is Biogen ’s Tysabri (natalizumab) biosimilar, Tyruko. The biosimilar is licensed to Sandoz , which bears responsibility for distribution and commercialisation. Tyruko was approved by the FDA for all multiple sclerosis (MS) settings where Tysabri is currently used, including relapsing-remitting MS, clinically isolated syndrome (CIS), and active secondary progressive disease, in addition to Crohn’s disease in August 2023.

Pictured: MRI scans of the brain/iStock, Nur Ceren Demir The European Commission has revoked the centralized marketing authorization for the generic versions of Biogen’s multiple sclerosis therapy Tecfidera (dimethyl fumarate), the company announced on Tuesday. The EC’s directive covers generic dimethyl fumarate products from companies such as Teva, Mylan, Accord, Polpharma and Neuraxpharm, while affirming Tecfidera’s exclusive marketing protection until February 3, 2025. Biogen in a statement said it “welcomes” the EC’s decision, which upholds data exclusivity and marketing protection laws in the EU. “Those laws are essential to protecting innovation,” according to the company. Tecfidera “is the only dimethyl fumarate treatment for multiple sclerosis that may be lawfully placed on the market for sale in the EU until that date,” Biogen indicated in its announcement, adding that it has already taken legal steps to protect its market protection rights for Tecfidera in the region. Biogen contends that it has enough supply of Tecfidera to cater to the entire European market. Tecfidera is an oral drug that won the FDA’s approval in March 2013 for the treatment of relapsing forms of multiple sclerosis. Its mechanism of action is not well understood but might exert its therapeutic effects by suppressing the expression pro-inflammatory genes, while altering the properties of immune cells to become more anti-inflammatory and preventing their infiltration into the central nervous system. Despite hitting the market around a decade ago, Tecfidera remains one of Biogen’s top assets. In the third quarter of 2023, the drug brought in $239.5 million in revenue, cementing its place among the company’s best-selling multiple sclerosis therapies, just behind Tysabri (natalizumab). For Biogen, Tuesday’s win over generics in Europe is a welcome deviation from its patent case in the U.S. In June 2020, U.S. District Judge Irene Keeley gutted Biogen’s key patent protecting Tecfidera, which was originally set to expire on February 2028, Fierce Pharma reported at the time. The pharma appealed the decision but in November 2021 an appellate court took Keeley’s side, agreeing that Biogen’s crucial patent was invalid. Biogen’s final defeat came in October 2022, when the U.S. Supreme Court denied to hear its case. According to medicine information platform Drugs.com, there are several generic dimethyl fumarate products available in the U.S. manufactured by companies including Accord Healthcare, Alkem Labs, Amneal and Mylan. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

The win in Europe follows a series of similar developments there. But in the U.S., it's a different story for Biogen's blockbuster. Following a significant loss at the U.S. Supreme Court last October, Biogen’s Tecfidera patent odyssey continues to spin in the company’s favor overseas. Tuesday, Biogen said the European Commission (EC) revoked marketing authorizations for generic versions of Tecfidera, also known as dimethyl fumarate, that are owned by copycat drugmakers Accord, Mylan, Neuraxpharm, Polpharma and Teva. The EC has confirmed full data and marketing protection for Tecfidera in Europe, the company said. Under the latest ruling, Tecfidera is now girded by marketing protection until Feb. 3, 2025, making it the only dimethyl fumarate treatment for multiple sclerosis that can be legally placed on the European market before then, according to the Massachusetts-based drugmaker. The company added that it’s kicked off legal action to defend its market protection rights. Biogen also says it has enough Tecfidera supply to provide the drug to the entire European market. Biogen’s latest win marks a positive turn for the company in its ongoing Tecfidera patent odyssey. The decision follows another win in Europe earlier this year. Back in May, the EC ruled that Biogen’s multiple sclerosis drug would have market protections until 2025. That outcome followed another March decision from the EU’s Court of Justice that went in Biogen’s favor and blocked generic versions of the company’s drug. Things haven’t gone so smoothly for Tecfidera in the United States, where Biogen last year took its patent case all the way to the Supreme Court. Stateside, Biogen’s exclusivity on Tecfidera originally wasn’t due to expire until 2028, but in 2020, a U.S. district court ruled that the med’s critical 514 patent was invalid. A November 2021 appeals court decision failed to revive the patent, which pushed Biogen to seek out a ruling from the High Court. Last October, however, the Supreme Court declined to hear the case, clearing the way for Viatris to continue marketing its generic version of the drug, which launched back in 2020. Tecfidera sales have been struggling since the generic launch in the U.S. The med's 2021 sales came in at $1.95 billion after reaching $3.84 billion the previous year, while in 2022, Tecfidera pulled in $1.4 billion.