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Microgram: fda-biosimilar-safety-scope

station__algovigilance__microgram-fda-biosimilar-safety-scope native (always callable) algovigilance pv-core Constructa Configa

FDA biosimilar safety study scope: determines comparative safety requirements by similarity level per FDA Guidance 'Biosimilar Comparative Analytical Assessment' (2025) and Interchangeability Guidance

Taxonomy

Linnaean classification joined from the algovigilance taxonomy index via the parent config's rank.

Rank	Value
domain	`Substrata`
kingdom	`Constructa`
phylum	`Configa`
class	`station-config`
order	`algovigilance`
family	`mcp-tool-config`

Characteristics:

substrate: config
domain: pv
lifecycle: continuous
authority: read
compounding: producer
io: agent-request → tool-response

Input schema

analytical_similarity stringrequired — Analytical similarity to reference: highly_similar, similar, residual_uncertainty
functional_similarity booleanrequired — Whether functional assays show comparable biological activity
seeking_interchangeability boolean — Whether applicant seeks interchangeability designation
immunogenicity_risk_level string — Immunogenicity risk: low, moderate, high

Example call

POST /api/mcp
Content-Type: application/json

{
  "jsonrpc": "2.0",
  "id": 1,
  "method": "tools/call",
  "params": {
    "name": "station__algovigilance__microgram-fda-biosimilar-safety-scope",
    "arguments": {
      "analytical_similarity": "",
      "functional_similarity": false
    }
  }
}

How to invoke from a client

From any MCP-aware client, add https://algovigilance.com/api/mcp as an MCP server, then call this tool by name. From a raw HTTP client, send the JSON-RPC body above to /api/mcp.

Agent-friendly formats

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/tools/algovigilance__microgram-fda-biosimilar-safety-scope/raw.md — this page's Markdown twin