Planning for 505(b)2 Commercial Success


Unlike generics and biosimilars, 505(b)2 regulatory products likely involve a unique claim. While 505(b)2 asset approval relies on reference product core clinical program data, ideal 505(b)2 candidates can include:

  • Drugs with new indications
  • Drugs with changes in dosage form, strength, formulation, dosing regimen or route of administration
  • New combination products
  • Prodrugs of an existing drug
  • Drugs with some new active ingredients

505(b)2 pathway drugs can be eligible for several types of market exclusivity, including orphan drug exclusivity (seven years), new chemical entity exclusivity (five years), “other” exclusivity (three years for a ‘change’ if certain criteria are met), and pediatric exclusivity (six months added to existing patent protection).

To maximize return on investment, 505(b)2 commercial readiness should include many of the same aspects that a new branded entity seeks to achieve:

  • Marketing: answer the “where to play?” and “how to win?” questions to define brand strategy and market development objectives
  • Medical Affairs: articulate the scientific platform and communication plan
  • Sales: define the go-to-market and training plan
  • Market Access: set the pricing and access goals and resource the team effectively to reach payers
  • Manufacturing: define the forecast, supply and distribution plan
  • Regulatory: plan for 505(b)2 pathway submission, submit a proprietary name, prepare a draft label, prepare OPDP submission for promotional material
  • Clinical: Data analysis in support of regulatory submission and scientific communication

Teams focused on establishing the marketing plan first will be best positioned to ensure appropriate resourcing and planning for other functional verticals. 505(b)2 drugs that differentiate with a wholly new indication may have significant market shaping and brand development to undertake, while prodrugs may launch much like a biosimilar with little differentiation and compete primarily on contracting. A well-established process for defining “where to play” and “how to win” should drive critical business decisions on positioning, messaging, go-to-market approach and forecast. Done early enough, this should even inform clinical and regulatory planning to achieve the optimal label for the target patient population.