Mylan Wins FDA Approval for First Advair Generic

Regulatory NewsRegulatory News | 31 January 2019 |  By 

The US Food and Drug Administration (FDA) late Wednesday approved the first generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for the twice-daily treatment of asthma in patients aged four years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).

Generating almost $80 billion in sales since its initial launch, competition-less Advair has been a reliable source of revenue for GSK, though in more recent quarters sales have declined. GSK said 2017 revenue for the drug was £3.13 billion ($4.23 billion). 

According to GoodRx, Advair prices increased by about 35% between January 2013 and 2017.

Mylan, which has yet to reveal its price for the generic, obtained approval to market its generic inhaler in three strengths: fluticasone propionate 100 mcg/ salmeterol 50 mcg, fluticasone propionate 250 mcg/ salmeterol 50 mcg and fluticasone propionate 500 mcg/ salmeterol 50 mcg. The generic inhaler will launch in the second half of February.

But winning approval of the generic version of Advair was not easy. "This milestone represents the culmination of an extensive research and development program and Mylan's more than $700 million of investment," Mylan CEO Heather Bresch said in a statement.

Earlier in 2018 and in 2017, Mylan received complete response letters (CRLs) from FDA for its generic version. Hikma Pharmaceuticals also received a CRL for its generic version of Advair. FDA told Hikma to conduct another clinical trial to get its generic approved and it anticipates another submission this year.

“FDA recognizes challenges companies face when seeking to develop hard-to-copy complex generics, such as drug-device combination products, including when the drugs are incorporated into inhalation devices like this,” said Anna Abram, FDA’s Deputy Commissioner for Policy, Planning, Legislation and Analysis. “We are committed to advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we’re prioritizing review of many applications covering proposed generic complex products for which a generic has not yet been approved.”

FDA commissioner Scott Gottlieb also noted that a series of guidance documents is coming to address regulatory and scientific challenges that make it generally more difficult to develop complex generics.

“We intend to issue draft guidance with recommendations on establishing active ingredient sameness. In addition, we’re going to help advance the development of new analytical tools and in vitro tests that may provide additional accurate, sensitive and reproducible tools to support approval of complex generic drugs,” Gottlieb said.


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Tags: Advair, generic, GSK, Mylan

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