With patent expiry drugs expected to reach record levels in the near
future, global regulators are expected to vet increased number of
applications and their task could only expected to get humongous as
these agencies are unable to hire additional manpower to shoulder sudden
surge in workload.

“It is unlikely that US and EU regulators
will expand their staff to any large extent given the current economic
climate where there is a need for governments to control costs of
operation unless the industry pays for more people to be employed. This
is based on the Prescription Drug User Fee Act that allowed the FDA to
recruit more staff in return for quicker assessment times,” Dr Mike
James, ex UK Regulator (MHRA) and Technical Director, Cambridge
Regulatory Services Ltd, UK told Pharmabiz in an email interaction.

For
companies, increased number of applications could mean slower
assessments and higher fees giving more reason for regulators to reject
inadequate or incomplete applications so that these dossiers do not clog
up the assessment system, he added.

Pricing and reimbursement
are separate issues in drug approvals. It is possible to gain approval
to sell (license) but not be able to negotiate a suitable reimbursement
price with the health care system in a country. This phenomenon is
common for expensive biotechnology drugs where the annual expenditure
for each patient can be in excess of $20 000. With limited budgets for
all health care funding agencies including insurance, the cost control
in budget allocation for drug purchase is the focus. In the wake of this
scenario, the regulatory agencies are looking for faster approval of
generic medicines and biosimilar products. It will see more companies
competing to bring down the prices of drugs.

The markets of EU
and US for generics are large in volume, but not in price when compared
to costs obtained by the originator products. But demand for generics
are bound to grow substantially in the next few years with a rise of an
ageing population and with many current blockbuster drugs expected to
lose patent and market exclusivity protection. It is estimated that
drugs going off patent over the next three years is valued at Rs.320,000 crore ( US$ 80 billion).

According
to Dr James, there are several barriers to enter the international
regulated markets for generics. Cost of doing business in the US and
Europe are higher than in India. This is because the modes of
pharmaceutical distribution in these developed countries are different
from India. The former needs a local partner to ease market entry and a
good local firm that understands the rules and culture are critical to
the successful launch of a new company and its products into these
markets.

Dr. James recommended that pharma and biotech companies
should diligently plan and understand the requirements of each market.
For instance, data generated for India will not automatically be
applicable for other regulated markets. Any development programme should
use international standards to maximize product acceptability in
multiple markets.

Also he suggested that companies with no prior
experience of the USA or EU regulatory framework should take
professional advice to ensure that their applications are not rejected
for proper compliance of guidelines.