Fda Drug Competition

Purple Book Biosimilar Entry Timeline

purple_book_biosimilar_entry_timeline

Read-onlyIdempotent

Chronologically summarize unique FDA-licensed 351(k) BLAs associated with a reference biologic. Returns approval dates, applicants, product names, reference products, and biosimilar versus interchangeable designations for entry analysis.

Input Schema

TableJSON Schema

Name	Required	Description	Default
`limit`	No	Unique 351(k) BLAs (1-100, default 50).
`reference_product`	Yes	Reference proper/proprietary name or related product name.

Output Schema

TableJSON Schema

Name	Required	Description	Default
`source`	Yes
`entries`	Yes
`returned`	Yes
`dataset_note`	No
`dataset_stale`	No
`dataset_updated`	No
`dataset_age_days`	No

Schema Changelog

Changes observed during successful MCP inspections. Dates show when Glama detected each change.

Changed3 schema fields changedSep 2, 2026
- addedOutput schema / properties / dataset_age_days
```
Added value: +{
+  "type": [
+    "number",
+    "null"
+  ]
+}
```
- addedOutput schema / properties / dataset_note
```
Added value: +{
+  "type": "string"
+}
```
- addedOutput schema / properties / dataset_stale
```
Added value: +{
+  "type": "boolean"
+}
```
AddedAug 6, 2026

TDQS

A4/5.0

Behavior4/5

Does the description disclose side effects, auth requirements, rate limits, or destructive behavior?

Annotations already cover the safety profile (readOnly, idempotent, non-destructive, openWorld), so the bar is lower. The description adds genuinely useful behavioral context beyond those hints: 'unique' signals deduplication of 351(k) BLAs, and 'chronologically summarize' signals temporal ordering and aggregation rather than a raw list.

Agents need to know what a tool does to the world before calling it. Descriptions should go beyond structured annotations to explain consequences.

Conciseness5/5

Is the description appropriately sized, front-loaded, and free of redundancy?

Two sentences with no filler: the first front-loads the core behavior and resource, the second lists return fields and the use case. Every sentence earns its place and nothing is redundant with the schema.

Shorter descriptions cost fewer tokens and are easier for agents to parse. Every sentence should earn its place.

Completeness4/5

Given the tool's complexity, does the description cover enough for an agent to succeed on first attempt?

For a simple two-parameter, read-only query tool with 100% schema coverage and an output schema, the description plus structured fields cover invocation and expectations well. The one gap is the missing routing guidance relative to the purple_book_* sibling family, but nothing essential for calling the tool correctly is absent.

Complex tools with many parameters or behaviors need more documentation. Simple tools need less. This dimension scales expectations accordingly.

Parameters3/5

Does the description clarify parameter syntax, constraints, interactions, or defaults beyond what the schema provides?

Schema description coverage is 100% — limit (1-100, default 50) and reference_product (proper/proprietary or related name) are both documented in the schema. The description's 'reference biologic' loosely echoes the reference_product parameter but adds no new parameter-level detail, so the baseline 3 applies.

Input schemas describe structure but not intent. Descriptions should explain non-obvious parameter relationships and valid value ranges.

Purpose5/5

Does the description clearly state what the tool does and how it differs from similar tools?

States a specific verb (chronologically summarize), a precise resource (unique FDA-licensed 351(k) BLAs associated with a reference biologic), and lists the returned fields (approval dates, applicants, product names, reference products, designations). The 'entry timeline' angle distinguishes it from the seven purple_book_* siblings covering biosimilar lists, interchangeables, and product search.

Agents choose between tools based on descriptions. A clear purpose with a specific verb and resource helps agents select the right tool.

Usage Guidelines3/5

Does the description explain when to use this tool, when not to, or what alternatives exist?

The phrase 'for entry analysis' implies a use case, but no alternatives or when-not-to-use guidance is provided. With seven purple_book_* siblings, including purple_book_biosimilars and purple_book_competition_profile, an agent gets no explicit cue for choosing this tool over them. Usage is implied rather than stated.

Agents often have multiple tools that could apply. Explicit usage guidance like "use X instead of Y when Z" prevents misuse.

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