Mylan’s stocks surge post FDA’s approval of its biosimilar Fulphila
Category: #health  By Dhananjay Punekar  Date: 2018-06-08
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Mylan’s stocks surge post FDA’s approval of its biosimilar Fulphila

The U.S. FDA has reportedly approved Neulasta’s biosimilar manufactured by Mylan N.V., a U.S. based generic & specialty pharmaceuticals firm. Incidentally, the biosimilar, called Fulphila, is the first knockoff of Amgen's bone marrow stimulant Neulasta that recently generated waves of anticipation in the U.S. pharma industry.

According to Reuters, last year, Neulasta, which is used in treating cancer patients, had contributed nearly 21% towards Amgen’s overall drug sales. Post the approval, Mylan’s share price witnessed a drastic increase after nearly eight weeks, closing at USD 39.98 on Tuesday. The impact of the FDA’s decision was also witnessed on the stock prices of pharma giants such as Novartis and Coherus Biosciences that are also trying to develop biosimilars of Neulasta.

Reports claim that Coherus’s stock price increased by 5.6%, while that of Novartis rose by 1.1%. However, the strategic move had a negative impact on the share prices of Amgen as its price dipped to USD 181.73. Sources cite that last year Amgen’s revenue from Neulasta declined by nearly 30% after Neupogen,  Neulasta’s short-acting version, received FDA approval. In fact, Amgen’s Neulasta sales in U.S. were approximately USD 3.93 billion in 2017.

The approval of Neulasta’s biosimilar is likely to help Mylan produce a revenue of nearly USD 100 million this year. Analysts predict that the revenue will surge to about USD 554 million in 2022. It is likely that revenue from the sales of the biosimilar may exceed market expectations.

Currently, Neulasta’s profiled syringe produces sales revenue worth USD 1.4 billion each year. With Mylan’s biosimilar being the only one to receive authorization from the country’s federal agency, it is going to offer a stiff competition to Amgen’s Neulasta.

Amgen & Mylan are fighting a legal battle over the drug copyrights. Amgen has claimed that Mylan’s biosimilar drug has violated two of its patented procedures used for purifying proteins in biological products.



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Dhananjay Punekar

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Dhananjay Punekar

Dhananjay Punekar presently develops content for a slew of portals, including Market Size Forecasters and Algosonline. A post graduate in mathematics and business administration, he worked in Infosys BPO Limited prior to switching his professional genre. As a content wr...

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