Providing sufficient demonstration of biosimilarity to alleviate fears and promote acceptance remains one of the major issues
facing biosimilars manufacturers. Demonstration of biosimilarity will increase physicians' willingness to prescribe biosimilars
and reduce patients' resistance to these products. In principle, biosimilarity should be relatively easy to prove for the
simple and well-characterized biologics such as insulin, epoetin, and human growth hormone. The larger and more complex biologics
such as monoclonal antibodies (mAbs), however, present a challenge. These biologics tend to be the most lucrative and attractive
prospects for biosimilar manufacturers, who must establish sophisticated development processes to realize their potential.
Rebates and service agreements between branded manufacturers and healthcare providers or insurers are likely to be a considerable
deterrent to the adoption of biosimilars. Biosimilars manufacturers must either offer better incentives than the branded companies
do or offset them through competitive pricing. Datamonitor anticipates that branded companies will defend their market share
aggressively against biosimilars, probably through competitive pricing. Biosimilar manufacturers must therefore contend with
the frequently longstanding relationships between branded companies, healthcare providers, and patients, and find a way to
mitigate them. The strategy may be straightforward for biosimilar manufacturers that are affiliated with branded companies.
But the traditional generic-drug company that is not accustomed to the marketing and promotion that will almost certainly
be required in the emerging biosimilars market faces a substantial challenge. Moreover, these companies may lack the logistical
and financial power to offer the same level of service and support that branded companies routinely offer. In an environment
such as this, a collaboration that unites the technical know-how of small companies with the marketing prowess of larger companies
will be critical.
Lessons from Europe
As the first region to introduce guidelines for the approval of biosimilars, Europe has emerged as the testing ground for
these products. In 2008, the European Medicines Agency (EMEA) said that a biosimilar approved through the pathway is as safe
and effective as any other EMEA-approved drug (5). Not surprisingly, all of the biosimilars were first launched in Germany,
the largest generic-drug market in Europe. Although a European regulatory pathway now exists, general acceptance and a path
to market—in terms of pricing, pricing, reimbursement, and distribution systems—remain to be established (6). Creating demand
among the key stakeholders is critical and requires information that counters branded companies' promotional efforts.
Lessons learned from Europe's hospital and retail markets should also be considered. Biologics in Europe tend to be dispensed
in hospitals, although there is considerable regional variation for molecules such as epoetin and filgrastim. In a hospital,
pharmacy managers and payers are likely to influence physicians' prescribing behavior, making this setting an attractive one
for biosimilars manufacturers. Moreover, anecdotal evidence suggests that patients are often unwilling to switch drugs after
leaving the hospital (1).
But drug acquisition through the tender process may make it difficult for biosimilars manufacturers—who may be less familiar
with the process or lack the established relationships—to sell to hospitals. Acquisition in the retail sector, while more
fragmented, is far more transparent, and competition based on price is a real possibility. This conclusion is partly borne
out by biosimilar epoetin alpha sales in 2008 in Germany, where uptake was almost eight times faster in the retail sector
than in hospitals (2).
Lessons from Japan
Although Japan is the second market to establish an approval pathway for biosimilars, the products are not expected to enter
the Japanese market until 2012 at the earliest. Biosimilars in Japan will be subject to the same approval process as branded
drugs, with the concomitant delays to which branded manufacturers have grown accustomed. The median approval time for new
drugs in Japan was 34.3 months in 2007 (7). Therefore, Datamonitor assumes that biosimilar approvals in Japan will take at
least three years. Only one biosimilar, epoetin, is known to have been submitted for approval, and market entry is likely
to occur significantly later than in the other markets.