BiosimilarFollow-on Biologic, Subsequent Entry Biologic
A biological product highly similar to an approved reference biologic, with no clinically meaningful differences in safety, purity, or potency.
Pricing & Market Access
Terms for how medicine prices are set and negotiated and how patients gain access to new treatments.
- Topic: Pricing & Market Access
- 40 terms
- Editor reviewed
Compassionate UseInvestigational Access, Emergency Treatment Access
A regulatory pathway letting patients with a serious condition access an investigational treatment outside a trial when no comparable alternative exists.
Conditional ReimbursementOutcomes-Based Reimbursement, Provisional Reimbursement
A coverage arrangement in which a payer reimburses a treatment provisionally, subject to collecting further evidence confirming its value within a set timeframe.
Confidential DiscountPrivate Discount, Undisclosed Rebate
A price reduction negotiated privately between a manufacturer and payer, keeping a higher public list price while offering a lower net price.
Data ExclusivityRegulatory Data Protection, Data Protection Period
A period during which regulators cannot rely on an originator's trial data to approve a generic or biosimilar competitor, distinct from patent protection.
Differential PricingPrice Differentiation, Market-Specific Pricing
A pricing strategy selling the same product at different prices in different markets, typically reflecting differences in ability to pay.
Drug PricingPharmaceutical Pricing, Medicine Price Setting
The setting and negotiation of medicine prices and payments across a specified product, purchaser, market and point in the supply chain.
Early Access SchemeEAMS, Pre-Approval Access Scheme, Early Access Programme
A regulatory programme letting patients with a life-threatening condition access a promising unlicensed medicine before full marketing authorisation, based on preliminary evidence.