Biosimilar

The regulatory process by which a pharmaceutical product receives authorisation for commercial sale, granted by agencies such as the FDA (US), EMA (EU), and MHRA (UK). Drug approval requires demonstration of safety, efficacy, and manufacturing quality through preclinical studies and clinical trials.

A pharmaceutical product that contains the same active ingredient, dosage form, strength, and route of administration as an originator (branded) drug and is demonstrated to be bioequivalent. Generic drugs can be manufactured and marketed after the expiry of the originator's patent protection and regulatory exclusivity periods.

The regulatory authorisation granted by the US Food and Drug Administration permitting a medical device to be marketed in the United States, typically through the 510(k) premarket notification pathway for devices that are substantially equivalent to an existing legally marketed device. FDA clearance is distinct from FDA approval (required for higher-risk Class III devices via the Premarket Approval pathway) and represents a significant regulatory intangible asset.

The sequential stages of human testing required before a new drug or medical device can receive regulatory approval. Phase I assesses safety in a small group, Phase II evaluates efficacy and dosing, Phase III confirms effectiveness in large populations, and Phase IV involves post-market surveillance.

A pharmaceutical product that generates annual revenue exceeding $1 billion, representing a transformational commercial success for its manufacturer. Blockbuster drugs — such as statins, biologics for autoimmune diseases, and oncology treatments — drive the majority of pharmaceutical industry profits and are among the most valuable intangible assets in existence.

The authorisation granted by a government or regulatory body permitting a company to manufacture, market, or sell a product or service in a specific jurisdiction. Regulatory approvals — including drug approvals (FDA, EMA), financial service licences (FCA, MAS), telecommunications licences, and environmental permits — are recognised as contract-based intangible assets in purchase price allocations under IFRS 3 and ASC 805 when they arise from contractual or legal rights.

A market approach valuation technique that estimates the value of a subject company by reference to the trading multiples of publicly listed companies with similar business characteristics. The method involves identifying comparable public companies, selecting appropriate valuation multiples (such as EV/EBITDA or P/E), making adjustments for differences in size, growth, risk, and marketability, and applying the adjusted multiples to the subject company's financial metrics.

Modifications applied to valuation multiples derived from comparable public companies or precedent transactions to account for differences between the reference companies and the subject being valued. Common adjustments address differences in size, growth rate, profitability, geographic mix, capital structure, and the presence or absence of a control premium.