Optimising Innovator Sourcing for Bio-Similar Development

By

DR. PIYUSH GUPTA (MBBS, MBA)

ASSOCIATE DIRECTOR – BUSINESS DEVELOPMENT
GNH USA

IN THIS PRESENTATION

Era Of Bio Therapuetics
Reverse Planning
Significance Of Source Markets
Effects On Registration, Costs And Time To Market
Key points in sourcing Bio-similar
Comparator Souring Organisation – Roles and Services.

1. ERA OF BIOTHERAPUTICS

Conventional Medication has been used and abused by Humanity for over a century now
Human body has started becoming immune to conventional medication
Antibiotic resistance is at it’s all time high
The next frontier in medicines is Bio-Therapeutics Targeting of Cells at DNA and Gene level

2. REVERSE PLANNING

What is Reverse planning ?
Conventional RnD approach do not work for Bio-similars development
Bio-similars are expensive to develop, clinical studies are more complex and Stability even more so.
Top down approach of planning the full RnD process, Trials, Studies and then looking for Comparators has led to looses of Millions of Dollors in:
- Excess stock
- Expired Stock
- Wrong Packs

REVERSE PLANNING

Reverse Planning:
- Start by identifying your Destination Markets
- For Example a Bio-similar to be registered in EU needs a EU sourced comparator from Innovator with EU number of the pack.
- While a Bio-similar for registration in RoW markets will accept comparator from any markets as long as it’s from the innovator.
- This reverse planning can SAVE millions of Dollars in sourcing by selecting the right source markets.

3. Signiﬁcance of Source Markets

Source Markets should be chosen based on your Destination markets
For Example if you plan to Target RoW Markets, there’s no point in souring products from US market
US products with NDC numbers are at least 3 time more expensive as compared to same brand in International packs
US stocks are difﬁcult to get, highly controlled, traced and the sheer cost makes the development process un-viable.
In contrast to this : An International pack from Europe / Eastern Europe is available at 1/3rd the cost, in Large quantities and with Pedigree Documents.

Market Intelligence

4. Effects on Registration

Ultimate goal of any development is to SELL the product
Sell – Fast and First to Market
Sell – At Most competitive price
Example : India is a Right Hand Drive Country – Is there any point launching a Left Hand Drive Car here ?
Similarly if your destination is RoW – there’s no point in Sourcing of US / EU stock for RnD
Lack of reverse planning : Only increase development cost hence the END product COST
Lack of product availability from US / EU markets – delays development
And off course you are not FAST or First to market

5.Key points in Sourcing Bio-Similars

Identify your Destination Markets First
Check availability, Pack descriptions, SPC etc… of your comparator in planning stage
Call for Pack photos, Pack Scans in planning stage
Estimate the Quantity, Frequency etc…. in advance
Understand availability issues for Comparators right in the beginning.
Tie up your source even before you start development process

6. CSO – Comparator Sourcing Organisation

While Development and RnD is the a focus of Manufacturers or CROs
Sourcing of Innovators / Comparators can be big challenge
An ideal CSO should be :
- WHO GDP Certiﬁed Site
- With validated Storage and Shipping systems
- With Global Reach
- Ability to source and transport products worldwide
- Knowledgeable about Global Market place
- In depth Experience in Sourcing, Imports and Exports

GNH USA and GNH

GNH India Pharmaceuticals: DGFT-recognised export house, licensed by the State FDA and DGFT to carry out imports and exports of drugs and related products, qualified person on site in the warehouse, WHO GDP certified by SGS
More than 15 years of industry experience
Over 220,000 products

GNH USA and GNH (continued)

Shipping and importing Globally to over 180 countries
Validated Storage and Shipping systems
Full Traceability and Pedigree for every supply
In Depth Market knowledge and Market intelligence
Complete Regulatory and compliance support until Market launch

Market Intelligence – 1 product – 2 packs ??

Other Resources

Our Unmatched Services

Our goal is to source, distribute and deliver pharmaceutical products to everyone who needs them most, and all without any of the unforeseen delays that you simply cannot afford.

Comparator Sourcing for Clinical Trials