By
Donald Zuhn --
In
a letter to the editor published
in this week's edition of The New England
Journal of Medicine, Dr. David Wheadon, Senior Vice President of the Pharmaceutical
Research and Manufacturers of America (PhRMA) Scientific & Regulatory
Affairs team, attempts to set the record straight regarding a follow-on
biologics (FOB) paper published in that medical journal last fall. The focus of Dr. Wheadon's criticism is
a NEJM paper written by a New York
patent attorney (Alfred Engelberg) and two Harvard professors (Dr. Aaron
Kesselheim and Dr. Jerry Avorn), in which the three authors contend that the FOB
legislation being proposed in the House and Senate -- which would provide 12
years of data exclusivity -- would "upset[] the delicate balance between
the interests of consumers and those of innovators" (see "NEJM Authors
Say Five Years of Data Exclusivity Would Be Sufficient"). Citing the Federal Trade Commission
(FTC) report on FOBs that was released last June (see "No One Seems Happy with Follow-on Biologics According to
the FTC"),
the three authors suggest that the FOB legislation currently pending in the
House and Senate (and which was proposed at the time the paper was originally published) be amended to "give the FDA the mandate to evaluate and
approve biosimilar drugs in a reasonable period, starting, as with
small-molecule products, 5 years after the approval of the original drug,"
and conclude that "[s]uch a compromise would best balance the need for
financial incentives with the need for competition, promoting access and
motivating important subsequent innovation."
Stating
that "the record should be set straight," Dr. Wheadon offers five
counterarguments to the Engelberg et al.
paper. First, he contends that
once an FOB regulatory pathway has been established, FOB manufacturers will
have "strong incentives to enter the market" -- namely, substantially
reduced developmental costs (Dr. Wheadon suggests that FOB manufacturers will
be looking at costs of between $10 million and $40 million, as compared to $1.2
billion for innovators) resulting from the FOB manufacturer's ability to use an
innovator's data to support its application for FDA approval. Next, Dr. Wheadon contends that
protection of this data, via an appropriate data exclusivity period, will be
critical given the less certain patent protection for biologic drugs (which he says is a result of the requirement that an FOB need only be similar, and not
identical, to the corresponding biologic drug). Third, Dr. Wheadon points out that data protection will not
eliminate competition because biologics will still have to compete with other
drugs. In particular, Dr. Wheadon notes that an FOB manufacturer can
bypass an innovator's data protection by generating its own data to provide support for FDA
approval. Fourth, in response to
some of the criticism regarding evergreening loopholes in the current
legislation, Dr. Wheadon observes that "changes to an innovator biologic
that do not affect the product's safety, purity, or potency would not qualify
for a new data-protection period."
Last, Dr. Wheadon asserts that recent (but as yet unpublished) data
indicates that "developers of less than one third of biologics had
recouped their research and development costs from 2003 through 2008," and
therefore "focusing on revenues associated with a select few biologics is
misleading."
Also
commenting about the Engelberg et al.
paper in a letter to the editor are Dr. Allan Pollock and Dr. Martin Zagari of
Amgen. Briefly, the Amgen researchers
seek to correct an error in the paper regarding the annualized cost of epoetin
alfa therapy for anemia of chronic renal disease. Whereas the Engelberg et
al. paper suggests that the cost of this therapy is $84,467 per patient,
Dr. Pollock and Dr. Zagari state the actual cost is $8,767 per patient. The Amgen researchers also note that the
Centers for Medicare and Medicaid Services (CMS) pays for 80% of this cost.
Two
of the authors of the original NEJM
paper, Alfred Engelberg, a New York patent attorney who represented the Generic
Pharmaceutical Industry Association and played a role in the passage of the
Hatch-Waxman Act in 1984, and Dr. Aaron Kesselheim, a patent attorney and
Instructor in Medicine at the Harvard Medical School, are given the last
word. In response to Dr. Pollock's
and Dr. Zagari's letter, Mr. Engelberg and Dr. Kesselheim explain that the $84,467
figure was the result of an arithmetic error in transcription, and that the
figure should have been $8,447 (somewhat lower than the number suggested by Dr.
Pollock and Dr. Zagari).
As
for Dr. Wheadon's letter, Mr. Engelberg and Dr. Kesselheim begin by noting that
Dr. Wheadon "does not challenge our central contention that the pending
biosimilar legislation will produce less competition and perpetuate higher
prices for biologic drugs," but "[r]ather, he attempts to justify
that outcome with a number of common arguments." First, the two authors suggest that Dr. Wheadon's $1.2
billion developmental cost estimate "has been widely disputed, and the
amount may be lower for biologics."
They note that for the drug alglucerase (Ceredase), the innovator
reported spending less than $58 million for development. The authors also dispute Dr. Wheadon's
FOB manufacturer cost estimate of $10 million to $40 million, stating that
"according to the FDA, clinical-trial requirements for biosimilars may not
be substantially different from those for new products."
As
for the currently pending FOB legislation, Mr. Engelberg and Dr. Kesselheim
argue that it "will grant a 12-year monopoly without any innovation
requirement and offers additional 12-year periods of exclusivity for minimal changes
to the original product." The
two authors conclude their letter by contending that if currently pending FOB
legislation is passed by Congress, "U.S. patients and insurers will
continue to pay unnecessarily high prices for [biologics] for decades to
come."
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