# run-fda-biosimilar-safety-scope

`station__microgram__run-fda-biosimilar-safety-scope` · external (needs EXECUTION_BACKEND_URL configured) · domain `microgram` · pv-relevance `pv-core`

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

> **Note:** This tool routes through an external execution backend. If `EXECUTION_BACKEND_URL` is unset on the server, calls return JSON-RPC error `-32603 "Tool execution backend not configured"`. Tools with `backend: native` execute in-process and are always callable.

## Agent metadata

- `idempotent`: unknown
- `read_only`: unknown
- `expected_latency_ms`: unknown (not yet contract-tested)
- `cost_tokens_estimate`: unknown

## Input schema

- `seeking_interchangeability` *boolean* (required) — Input parameter: seeking_interchangeability
- `immunogenicity_risk_level` *string* (required) — Input parameter: immunogenicity_risk_level
- `analytical_similarity` *string* (required) — Input parameter: analytical_similarity
- `functional_similarity` *boolean* (required) — Input parameter: functional_similarity

## Example call

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

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

## Related

- [/tools](/tools) — all 3062 tools
- [/tools/microgram__run-fda-biosimilar-safety-scope](/tools/microgram__run-fda-biosimilar-safety-scope) — HTML page
- [/tools/microgram__run-fda-biosimilar-safety-scope/json](/tools/microgram__run-fda-biosimilar-safety-scope/json) — JSON form (agent-friendly)
- [/api/mcp](/api/mcp) — endpoint
- [/AGENTS.md](/AGENTS.md) — agent guide