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Abstracts: A product launch is often a milestone
event for a biopharma manufacturer. Years of effort have
gone into clinical trials and regulatory approvals, and
manufacturing, marketing and patient-outreach efforts
have been made. The product owner only awaits the final
FDA approval, and then wants to get the product as
broadly distributed as possible, in the shortest time
possible. It is becoming a more common industry practice
to work with an outsourced services provider to carry
out this launch. There are responsibilities that the
services provider can take on; there are those that are
better kept in the hands of the product owner. Working
with a services provider has the potential to take
advantage of economies of scale—the services provider
might have warehouses, vehicles and personnel that
routinely handle high volumes of product distribution
efficiently and accurately, and to maintain these
capabilities at a cost that is less than the individual
manufacturer’s would be.
This article will review the critical decisions to make
when considering, and then working with, an outsourced
services provider. A guiding principle to keep in mind:
Every product launch is different. Each launch should be
evaluated on the basis of its own requirements.
Types of product launches
Just as there are many types of biopharmaceutical
products, there are many types of launches. An analysis
of how to handle a product launch should begin with an
evaluation of the requirements of that launch.
Here are the most common categories
1. Branded pharmaceutical (conventional oral solid)
2. Generic pharmaceutical – first to market
3. Generic pharmaceutical – second or later launch
4. Specialty (parenteral, temperature-controlled,
drug/device combination, etc.)
5. Launch through selected distribution channel
(full-line wholesaler; specialty distributor; limited
distribution specialty pharmacy, clinic, etc.)
The model that most analysts of the biopharma industry
look at is the introduction of a potential blockbuster
branded product—the ones that might address a condition
in an entirely new way with a first-of-its-kind pathway.
These blockbusters have become progressively more rare
in recent years. Meanwhile, hundreds of specialty
products, generics, or products intended for specific
channels (such as the hospital pharmacy) are being
introduced. These products can require launch logistics
to be planned as carefully as those for the
blockbusters. In 2008, for example, FDA approved 20 new
molecular entities (NMEs or branded pharmaceutical), but
also 91 generics, frequently launched by 5-15 companies,
of various formulations. The overall approval process by
the FDA can take 7 years or more, starting from the
identification of an NME. The planning for an NME
product launch can begin as long as two years in advance
of the expected approval date (shorter for most
generics).
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