Tom Polen
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The market for biotherapeutics has grown significantly since the first biologic drug was launched over 50 years ago. More
than 250 biologic molecules have been developed and launched since 1996, and today biologics account for nearly 30% of compounds
in the drug-development pipeline.
Recently, research and development (R&D) resources have focused not only on new molecular entities but also on improvements
to commercially available products. Reformulations now comprise nearly 50% of new drug application (NDA) approvals at the
US Food and Drug Administration (FDA).2 At drug-delivery companies focusing on injectable therapeutics, over 50% of the molecules in the pipelines are biologics,
with many projects focused on developing sustained-release formulations.3The challenge for drug makers, however, is to bring about these improvements while addressing the added packaging, manufacturing,
and formulation challenges inherent in biologics, due to their unique sizes, structures, and stability profiles. More than
95% of large molecules are administered either through intravenous (IV) infusion or through subcutaneous injection,4 routes of administration that are highly efficacious yet undesirable to many patients. As a result, new technologies continue
to emerge to improve administration and storage of these molecules.
ENHANCED PACKAGING AND FORMULATION STRATEGIES 
Table 1. Selected packaging and formulation strategies for differentiating biologics
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Life cycle management through enhanced packaging and newer drug-delivery technologies may ensure that a biologic compound's
commercial potential is fully realized and that drug makers can stay ahead or at parity with the competition. Depending on
a company's situation and time frame, a number of improvements can manage a product's life cycle (Table 1).
In the short term, drug makers are moving toward enhanced packaging that allows for safer, more intuitive reconstitution of
lyophilized powder formulations and less complicated administration of biologics.
Mid-range improvements typically involve improved drug-delivery devices, a substantial growth area for drug manufacturers.
Industry analysts predict that over the next three to four years the sale of biologics packaged with a device will show higher
growth than the same product packaged alone, driven by the market appeal of devices that make administration of biologics
easier.4
Quick Recap
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Long-term improvements involve reformulations to reduce the frequency of administration or to enable less invasive treatment,
such as pulmonary inhalation.
The best approach for a particular biologic compound depends on the molecule's market environment, point of use, and the company's
short- and long-term strategy for its product and business.
SOLUTIONS FOR SUBCUTANEOUS AND INTRAMUSCULAR INJECTABLES
Today approximately 75% of biologics are administered via subcutaneous or intramuscular injection.4 Most recent advancements in drug-delivery technologies related to injectable biologics have focused on devices and technologies
that improve safety, patient compliance, and convenience in both administration and storage.
6–18 Months
Short-term strategies primarily deliver improvements in convenience, compliance, or improved safety for healthcare workers
as well as patients.
