Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Biosimilar registration (comparability route)

Brazil · Brazilian Health Regulatory Agency · Biosimilars

Biosimilar applicationHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

365 days

law

Steps

12 requirements

Application fee

What is the Biosimilar registration (comparability route) in Brazil?

A biosimilar is a biological medicine highly similar to a comparator already registered by Anvisa on a complete dossier. The company runs a stepwise comparability exercise: analytical, then nonclinical and clinical studies, all comparative. Biological products that can be shown comparable to a registered comparator. Such products cannot use the individual route.

What are the steps of the Biosimilar registration (comparability route)?

1. Optional pre-submission guidance; 2. File the registration petition; 3. Technical review (365 days); 4. Technical requirements (clock stopped); 5. Decision published; 6. Public assessment report.

Outcome: Registration published in the Official Gazette, valid for 10 years. Valid for 10 years.

Legal basis: Anvisa RDC 55/2010; Anvisa RDC 875/2024; Anvisa RDC 948/2024

How the pathway works

Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

About 365 days end to end with the official step targets. Targets, not actual times.

Steps

In order, with the official target for each step

1. Optional pre-submission guidanceonly in some casesBefore filing, the agency can give guidance through protocol reviews, meetings or its service channels. This guidance is not binding.
2. File the registration petitionThe company files the dossier electronically and pays the inspection fee.
3. Technical review365 daysThe agency reviews quality, safety and efficacy. The legal maximum for an ordinary registration decision is 365 days from filing. The agency may extend it once by up to one third.
4. Technical requirements (clock stopped)clock stopped, only in some casesQuestions are sent in one consolidated request. The clock stops until the company answers.
5. Decision publishedThe decision is published in the Official Gazette (Diário Oficial da União).
6. Public assessment reportAfter the decision, the agency publishes a public assessment report with confidential data removed.

Official time targets

Targets, not actual review times

Legal time limitlaw. Official maximum time for the agency decision. It is a target in the rules, not an observed review time. Time the applicant spends answering questions is not counted.

365 days

Fees

Official amounts in the local currency

Fee	Amount
No fees published.

Other routes in Brazil: Registration of a new biological product (individual development route), Priority review of a registration petition, Special procedure for new medicines for rare diseases, Registration under a commitment term, Optimized analysis using an equivalent foreign authority, Good manufacturing practice certification (CBPF). See all routes on the Brazil page or explore them in the Regulatory section.

Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (21 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.

Reference approval

Comparator registered in Brazil on a complete dossierThe comparator is a product registered by Anvisa on a complete dossier, used through all steps. A comparator bought abroad is allowed if registered by an equivalent foreign authority recognized by Anvisa and made by the same manufacturers, or with a bridging study.

Quality and manufacturing

Analytical comparabilityComparison of primary and higher order structure, purity and impurities, functional characterization and stability.

Nonclinical data

Nonclinical in vivo studiesRelevant pharmacodynamic studies and repeated dose toxicity studies. Animal studies can be waived with a technical and scientific justification.

Clinical data

Comparative clinical studiesPharmacokinetic, pharmacodynamic, immunogenicity, safety and efficacy studies, all comparative. Some can be waived when comparability is high and justified.

Other

Extrapolation of indications(in some cases)Extrapolation to other indications follows specific guides, using guides of recognized equivalent foreign authorities where Anvisa has none.
Inspection fee paid before filingThe Health Surveillance Inspection Fee (TFVS) must be paid when the petition is filed.
Dossier format: CTD is allowed(optional)The technical dossier can be organized in the Common Technical Document (CTD) format. Where national rules are missing or incomplete, companies may follow ICH or WHO guidelines.

Local presence

Brazilian company with an operating authorizationThe applicant must be a company in Brazil with an Anvisa operating authorization (AFE): to manufacture, when the medicine is made in Brazil, or to import, when it is made abroad. The applicant becomes the registration holder.

Inspection

Good manufacturing practice certificateEach manufacturing site needs a valid Anvisa GMP certificate, or a pending request for one. If only a request exists, the registration decision waits until the certificate decision is made. The law now ties medicine registration to proof of GMP certification for both domestic and foreign manufacture.

Language

Translations(in some cases)Certificates and other declarations in a foreign language need a sworn translation, except documents in English or Spanish.

After approval

PharmacovigilanceThe holder must monitor adverse events under good pharmacovigilance practice. Serious adverse events in Brazil must be reported within 15 calendar days, urgent safety issues within 72 hours, and the holder must prepare periodic benefit-risk reports.
Registration lasts 10 yearsMedicine registration is valid for 10 years. Renewal needs proof that the medicine was sold during at least the last two thirds of the validity period.

Biosimilar registration (comparability route)

What is the Biosimilar registration (comparability route) in Brazil?

What are the steps of the Biosimilar registration (comparability route)?

How the pathway works

Timeline with clock stops

Steps

Official time targets

Fees

Requirements

Reference approval

Quality and manufacturing

Nonclinical data

Clinical data

Other

Local presence

Inspection

Language

After approval