biosimilar: meaning, definition, pronunciation and examples
C1/C2Technical/Medical/Regulatory
Quick answer
What does “biosimilar” mean?
A biological product highly similar to an already approved reference biologic, with no clinically meaningful differences in safety and efficacy.
Audio
Pronunciation
Definition
Meaning and Definition
A biological product highly similar to an already approved reference biologic, with no clinically meaningful differences in safety and efficacy.
A medical product derived from living organisms, designed to be nearly identical to an existing biologic drug, following patent expiration, but produced through separate manufacturing processes.
Dialectal Variation
British vs American Usage
Differences
No significant lexical differences. Usage is consistent across both varieties within professional contexts. The regulatory frameworks (EMA in Europe, FDA in the US) are often referenced.
Connotations
Neutral technical term. In public discourse, may be associated with debates on drug affordability, innovation, and patient access.
Frequency
Equally frequent in professional medical and pharmaceutical writing in both regions. Rare in everyday conversation.
Grammar
How to Use “biosimilar” in a Sentence
The biosimilar [VERB: is approved/shows equivalence/enters the market] for [INDICATION].[COMPANY] [VERB: develops/manufactures] a biosimilar to [REFERENCE PRODUCT].Vocabulary
Collocations
Examples
Examples of “biosimilar” in a Sentence
noun
British English
- The first infliximab biosimilar received EMA authorisation in 2013.
- Switching to a biosimilar can yield significant savings for the NHS.
American English
- The FDA's approval of the adalimumab biosimilar expanded treatment options.
- Insurers may prefer biosimilars due to their lower cost.
Usage
Meaning in Context
Business
The biosimilar segment is projected to grow by 15% annually, driven by patent expiries.
Academic
Comparative clinical studies are fundamental to establishing biosimilarity.
Everyday
My doctor said a biosimilar might be a more affordable option for my treatment.
Technical
The biosimilar demonstrated pharmacokinetic equivalence within the pre-defined acceptance margins.
Vocabulary
Synonyms of “biosimilar”
Neutral
Weak
Vocabulary
Antonyms of “biosimilar”
Watch out
Common Mistakes When Using “biosimilar”
- Using 'generic' interchangeably with 'biosimilar' (generics are for simple chemical drugs; biosimilars for complex biologics).
- Pronouncing it /ˈbaɪoʊˌsɪmɪlər/ with primary stress on the first syllable.
FAQ
Frequently Asked Questions
No. Generics are identical copies of small-molecule chemical drugs. Biosimilars are highly similar but not identical versions of large, complex biologic drugs derived from living cells.
Yes. Biosimilars are rigorously evaluated by regulatory agencies (like the EMA or FDA) to ensure they have no clinically meaningful differences in safety, purity, and potency compared to the reference product.
They create competition after biologic patents expire, increasing patient access to effective treatments and potentially reducing healthcare costs significantly.
It depends on national regulations and specific product designation (e.g., 'interchangeable' status in the US). Often, substitution requires physician agreement or is governed by specific laws.
A biological product highly similar to an already approved reference biologic, with no clinically meaningful differences in safety and efficacy.
Biosimilar is usually technical/medical/regulatory in register.
Biosimilar: in British English it is pronounced /ˌbaɪ.əʊˈsɪm.jə.lər/, and in American English it is pronounced /ˌbaɪ.oʊˈsɪm.jə.lɚ/. Tap the audio buttons above to hear it.
Learning
Memory Aids
Mnemonic
BIO (life) + SIMILAR (alike) = a medicine from living organisms that is highly alike to an existing one.
Conceptual Metaphor
A biosimilar is a NEAR-PERFECT REPLICA or a CLOSE COUSIN (not an identical twin) of the original biologic.
Practice
Quiz
What is a key regulatory requirement for a biosimilar?