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almost identical to a drug manufactured by anothe
r company whose patent has expired. In many cases, however, a single original medication can have as many as 200 patents and exclusivities attached to it, according to Julie Maréchal-Jamil, director of Biosimilar Policy & Science, Medicines for Europe, who is raising the question of whether this is in keeping with the intent of the patent system. “A particular concern is the increasing number of patents protecting indications that can be used to delay the access for patients, as our pharma industry has experienced with certain cancer medicines in Eastern Europe,” says Maréchal-Jamil. “This extensive patent landscape adds to the risk of developing biosimilar medicines.” intense discussions with regulatory authorities, such as the U.S. Federal Drug Administration (FDA) and the European Medicines Association (EMA), about regulatory issues to understand in detail their requirements for a specific development program. This includes the analytical methods to apply for analytical biosimilarity exercises and the design of clinical trials, says Martin Åmark, CEO/IR of Xbrane Biopharma AB, a Swedish biotechnology company that is developing biosimilars. To get the necessary advice, “We have engaged with specialist consulting groups and also participated with a scientific advisory group,” notes Åmark. “We are targeting the European and U.S. markets.” The quality pre-clinical and clinical comparability exercises needed to develop biosimilars also requires extensive amounts of time and money, according to Maréchal-Jamil. What this means for drug devel-opers is Xbrane expects to launch its first biosimilar in 2022. “You need to have the scientific know-how to develop these products and the financial resources to push them through the trials,” he says. As a good omen for the biosimilar industry, companies in Finland, Denmark and Sweden prevailed in the first patent dispute in Finland and Denmark. In March, the Finnish Market Court ruled against a motion for a preliminary injunction against MSD Finland Oy filed by F. Hoffman-La Roche AG, Roche Oy and Genentech Inc., and in Denmark, the Maritime and Commercial High Court in Copenhagen denied Roche and Genentech preliminary injunctions against MSD Danmark, Samsung Bioepis and Biogen (Denmark) Manufacturing. F. Hoffman-La Roche and Genentech argued that MSD Finland Oy infringed upon Roche and Genentech’s rights, according to the Finnish part of a European product patent, by marketing and selling a biosimilar drug in Finland. According to the court, it was unlikely MSD Finland would infringe on the rights of the companies that produced the original drug and was free to continue selling its drug to Finnish hospitals. In Denmark, Genetech and Roche claimed MSD Danmark, Samsung Bioepis and Biogen were infringing on their rights, according to the Danish section of a European product patent. NORDIC LIFE SCIENCE 109