Prabotulinumtoxin A biosimilar is under clinical development by Daewoong Pharmaceutical and currently in the Phase I, Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Prabotulinumtoxin A biosimilar’s likelihood of approval (LoA) and phase transition for Blepharospasm took place on 14 Oct 2021, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Prabotulinumtoxin A biosimilar Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Prabotulinumtoxin A biosimilar overview

Prabotulinumtoxin A (Nabota) is a biosimilar of clostridium botulinum A toxin. It is a protein produced by the bacterium Clostridium botulinum. It is formulated as injection powder solution for intradermal and intramuscular route of administration. Nabota is indicated for muscle spasticity, and blepharospasm (eyelid spasms).

It is under development for the treatment of blepharospasm, sleep bruxism, gastroparesis and spasmodic torticollis (cervical dystonia), unspecified musculoskeletal disorders (benign masseteric hypertrophy). It is administered through intramuscular and intradermal routes as a powder for solution.

Daewoong Pharmaceutical overview

Daewoong Pharmaceutical, a subsidiary of Daewoong Co Ltd, is one of the leading manufacturers and distributors of prescription drugs in South Korea. It offers prescription drugs, quasi drugs, healthcare products and APIs. The company produces products in the forms of tablets, capsules, ointments, injections, liquids, and sprays. It offers its products for the therapeutic conditions of bone and joint diseases, cardiovascular diseases, central nervous system diseases, circulatory system, dermatological, gastrointestinal, and respiratory remedies, among others. It also carries out development and commercialization of products through in-licensing, co-marketing, and co-promotion. The company operates in Japan, the US, Canada, Swiss, Germany and across Asia including Indonesia, China, Vietnam, Israel, Thailand, and India. Daewoong Pharmaceutical is headquartered in Seoul, South Korea.

Quick View Prabotulinumtoxin A biosimilar LOA Data

Report Segments
  • Biosimilar
Drug Name
  • Prabotulinumtoxin A biosimilar
Administration Pathway
  • Intradermal
  • Intramuscular
Therapeutic Areas
  • Central Nervous System
  • Gastrointestinal
  • Musculoskeletal Disorders
  • Ophthalmology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.