- MODULE 1
Biosimilars
Generic drugs are usually identical to the original pharmaceutical on which they are based. Biosimilars,
on the other hand, are not required to be exactly the same as the reference product. However, they
must provide the same therapeutic benefit to patients that the reference product does.
The FDA will not approve a biosimilar unless it has the same dosage form, strength, and mechanism of
action as the reference product it imitates. It must be proved to have the same safety and effectiveness
as the original, with no additional risks or downsides. The FDA must also approve the factories and
laboratories in which the biosimilars are manufactured.
Whereas generic drugs are made through chemical synthesis, biosimilars are produced from living cells.
Because of the high costs of testing and manufacturing biosimilars, they will rarely be as inexpensive as
generic drugs. However, as the patents on reference products run out, pharmaceutical companies will
rush to fill that gap with biosimilars, and the cost will come down as competition grows. Analysts expect
biosimilars, despite their complexity compared to generic drugs, to occupy a significant segment of the
pharmaceutical market in the years to come.
Questions 1-4
Biosimilars.......
⒈ What is the main idea of the passage?
A) Generic drugs remain the cheapest & easiest drugs for patients to use & doctors to prescribe.