10 Drugs in Pre-Registration Phase Have Potential to Reach Blockbuster Status by 2025

Out of all the drugs that are currently in the pre-registration phase and are expected to launch in 2020, 10 have the potential to reach blockbuster status over the next 6 years, according to GlobalData, a leading data and analytics company.

Amgen and Allergan’s biosimilar candidate to Roche’s Rituxan (rituximab) shows the greatest potential of these drugs. It is projected to reach almost $4 billion in annual sales by 2025, far above the predicted sales for other blockbusters in this group, which will all amass $1 billion to $2 billion in annual sales in the next 6 years.

Valentina Gburcik, PhD, Senior Director of Cardiovascular and Metabolic Diseases, Gender Health and Digital at GlobalData, comments “The competitive pricing of the biosimilar drug will help its wider use, and the drug will steal a significant proportion of patient share from the mega-blockbuster Rituxan.”

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Other than one biosimilar, all of the hopefuls are innovator drugs that span several therapy areas – mainly oncology and central nervous system (CNS).

According to GlobalData’s pharma analyst consensus forecast, the oncology and hematology pre-registration pool of potential blockbusters features innovator drugs that target triple-negative breast cancer, hemophilia A, and various types of lymphoma. They are all biologics with a unique mechanism of action, including a gene therapy (BioMarin’s Valoctocogene roxaparvovec) and a cellular immunotherapy (Bristol-Myers Squibb’s Lisocabtagene maraleucel). The CNS drugs dominate the pre-registration portfolio of potential blockbusters, with four out of ten drugs coming from this space.

Gburcik adds “The high cost of biologic oncology and hematology therapies coupled with high unmet needs in target patient populations will contribute to the soaring revenues from these drugs. In the CNS space, Bristol-Myers Squibb’s Ozanimod and Biohaven’s Zydis are entering the crowded and competitive spaces of multiple sclerosis and migraine, respectively, where the drugs will capture a substantial market share thanks to their differentiated efficacy and safety profiles. On the other hand, Roche’s Risdiplam and Zogenix’s Fintepla target spinal muscular atrophy and some forms of epilepsies in childhood, respectively – all rare disease areas with high unmet needs.”

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