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patents for REMICADE®in certain countries in Europe expired in February 2015. Biosimilar versions of REMICADE®have
been introduced in certain markets outside the United States, resulting in a reduction in sales of REMICADE®in those
markets. Additional biosimilar competition will likely result in a further reduction in REMICADE®sales in markets outside
the United States. The timing of the possible introduction of a biosimilar version of REMICADE®in the United States is
subject to enforcement of patent rights, approval by the FDA and compliance with the 180-day notice provisions of the
Biologics Price Competition and Innovation Act (the BPCIA). On February 9, 2016, the Arthritis Advisory Committee of
the FDA recommended by a vote of 21-3 to approve the first investigational biosimilar infliximab across all eligible
indications in the United States. There is a risk that a competitor could launch a biosimilar version of REMICADE®
following FDA approval (subject to compliance with the 180-day notice provisions of the BPCIA), even though one or
more valid patents are in place. Introduction to the U.S. market of a biosimilar version of REMICADE®will result in a
reduction in U.S. sales of REMICADE®. In 2015, U.S. sales of REMICADE®were $4.5 billion. The launch of a biosimilar
version of REMICADE®in the U.S. is not expected to have a material adverse effect on the Company’s results of
operations and cash flows in 2016. See Note 21 to the Consolidated Financial Statements for legal matters regarding the
REMICADE®patents.
Infectious disease products sales were $3.7 billion, a decline of 34.7% from 2014, which included an operational
decrease of 27.6% and a negative currency impact of 7.1%. Competitive products to the Company’s Hepatitis C
products, OLYSIO®/SOVRIAD®(simeprevir) and INCIVO®(telaprevir), had a significant negative impact on U.S. sales
and will continue to have a negative impact on future sales. The decline of Hepatitis C sales was partially offset by sales
growth of EDURANT®(rilpivirine) and sales of PREZISTA®/ PREZCOBIX®/REZOLSTA®(darunavir/cobicistat).
Neuroscience products sales were $6.3 billion, a decrease of 3.5% from 2014, which included an operational growth of
5.0% and a negative currency impact of 8.5%. The U.S. sales growth of CONCERTA®/methylphenidate was primarily
due to a therapeutic equivalence reclassification of generic competitors by the FDA in November 2014. Strong sales of
INVEGA SUSTENNA®/XEPLION®/INVEGA TRINZA®(paliperidone palmitate) were primarily due to increased market
share and the launch of INVEGA TRINZA®. Neuroscience products sales were negatively impacted by the U.S. divestiture
of NUCYNTA®(tapentadol) and lower sales of RISPERDAL®CONSTA®(risperidone).
Oncology products achieved sales of $4.7 billion in 2015, representing an increase of 5.3% as compared to the prior
year. Oncology products growth of 5.3% included operational growth of 17.7% and a negative currency impact of 12.4%.
Contributors to the growth were strong sales of IMBRUVICA®(ibrutinib) due to the approval of new indications, additional
country launches and strong patient uptake. Additionally, sales of ZYTIGA®(abiraterone acetate) grew in the U.S. due to
market growth partially offset by share decline, and strong growth in Asia and Latin America was partially offset by lower
sales in Europe due to competition.
Cardiovascular/Metabolism/Other products achieved sales of $6.4 billion in 2015, representing an increase of 15.1% as
compared to the prior year due to strong sales of XARELTO®(rivaroxaban) and INVOKANA®/INVOKAMET®
(canagliflozin). PROCRIT®/EPREX®(Epoetin alfa) sales were impacted by competition.
14 •Johnson & Johnson 2015 Annual Report