# Biosimilar manufacturing and comparability

Source: https://onco.cc/technologies/biosimilar-manufacturing/  
OnCo record `biosimilar-manufacturing` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A biosimilar is a copy of an antibody drug made by a different company in different cells. It cannot be identical, so the maker must prove the copy behaves the same in the laboratory and in patients. Biosimilars of trastuzumab, bevacizumab and rituximab have cut the cost of these drugs sharply.

## Summary

Because a biologic is defined by its process, a biosimilar developer starts from scratch: it builds a new CHO cell line expressing the same amino acid sequence, develops a process whose glycan pattern, charge variants, aggregates and potency fall within the range of many lots of the reference product, and runs analytical, pharmacokinetic and usually one comparative clinical trial. The EU approved the first biosimilar in 2006 and the first oncology antibody biosimilars in 2017; the FDA approved Zarxio (filgrastim, Sandoz) in 2015 as the first US biosimilar, Mvasi (bevacizumab, Amgen) and Ogivri (trastuzumab, Mylan and Biocon) in 2017, and Truxima (rituximab, Celltrion) in 2018. Several biosimilars of each now compete, made by Celltrion in Incheon, Samsung Bioepis, Amgen, Pfizer, Sandoz, Biocon in Bengaluru, Dr Reddy's and Intas among others.

Manufacturing is where the value lies: the same CHO culture, Protein A purification and fill-finish chain as the originator, run by companies competing on cost of goods, so biosimilar makers were early adopters of high-titre processes and single-use plants. Regulators police them with the same GMP inspections and with comparability rules (ICH Q5E) whenever a process changes. Uptake is high in Europe and rising in the United States; in low- and middle-income countries biosimilar trastuzumab is often the only affordable route to HER2-directed therapy.

## Fields

- Kind: Technology
- Status: standard-of-care
- Last checked: 2026-09-17
- Tags: manufacturing-wave
- Principle: Reverse engineering of an antibody's quality attributes to within the reference product's range, proved by analytical similarity and confirmatory clinical data.
- Since: 2006
- Strengths: Large price reductions for essential antibodies; Adds suppliers and resilience; Pushes manufacturing efficiency
- Limitations: Development still costs hundreds of millions; Interchangeability and substitution rules vary by country; Patent thickets delay launch

## Sources

- FDA: biosimilars: https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars
- EMA: biosimilar medicines: https://www.ema.europa.eu/en/human-regulatory-overview/biosimilar-medicines-overview
- Wikipedia: https://en.wikipedia.org/wiki/Biosimilar

## Connected records

- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/), [Diffuse large B-cell lymphoma](https://onco.cc/cancers/dlbcl/), [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/)
- fronts: [Immunotherapy](https://onco.cc/fronts/immunotherapy/), [Supportive Care & Survivorship](https://onco.cc/fronts/supportive-care/)
- technologies: [Antibody manufacturing (CHO bioprocessing)](https://onco.cc/technologies/monoclonal-antibody-manufacturing/), [Downstream purification (Protein A capture, viral clearance, polishing)](https://onco.cc/technologies/downstream-purification-chromatography/), [Global oncology and access in low- and middle-income countries](https://onco.cc/technologies/global-oncology-access/), [GMP, inspections, Form 483s and warning letters](https://onco.cc/technologies/pharmaceutical-gmp-inspections/), [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/), [Sterile fill-finish and lyophilisation](https://onco.cc/technologies/sterile-fill-finish/)
- drugs: [Bevacizumab](https://onco.cc/drugs/bevacizumab/), [Filgrastim (G-CSF)](https://onco.cc/drugs/filgrastim/), [Pegfilgrastim](https://onco.cc/drugs/pegfilgrastim/), [Rituximab](https://onco.cc/drugs/rituximab/), [Trastuzumab](https://onco.cc/drugs/trastuzumab/)
- companies: [Amgen](https://onco.cc/companies/amgen/), [Biocon](https://onco.cc/companies/biocon/), [Celltrion](https://onco.cc/companies/celltrion/), [Dr. Reddy's Laboratories](https://onco.cc/companies/dr-reddys/), [Intas Pharmaceuticals (Accord Healthcare)](https://onco.cc/companies/intas/), [Pfizer (incl. Seagen)](https://onco.cc/companies/pfizer/), [Samsung Bioepis](https://onco.cc/companies/samsung-bioepis/), [Sandoz](https://onco.cc/companies/sandoz/), [Viatris](https://onco.cc/companies/viatris/)
- bottlenecks: [Most of the world has almost no cancer care](https://onco.cc/bottlenecks/b-global-access/), [Prices and value](https://onco.cc/bottlenecks/b-drug-pricing/)

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