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Spectrum Pharmaceuticals, Inc. Message Board

  • joesolomon333 joesolomon333 Jun 12, 2013 11:58 PM Flag

    tboone - Zevalin

    Since you raised the patent expiration issue, would you like to expound further on this subject to educate all of us?
    "Zevalin is made by Spectrum Pharmaceuticals, Inc. At this time, it is not available in generic form.

    When Will a Generic Version Be Available?
    Zevalin belongs to a group of medications known as monoclonal antibodies. Like other monoclonal antibodies, Zevalin is considered a "BIOLOGIC" product. Examples of biologics include blood products, vaccines, enzymes, and certain medicines produced by biotechnology methods. Biologics are under different regulations than most other prescription medications.

    Biologic products are medicinal products made using natural resources, such as human and animal cells or microorganisms. These cells or organisms are used to make a complex mixture of proteins or molecules. While other prescription medicines have known and reproducible chemical structures, most biologics are not so easily characterized because of their complexity. This can make it difficult for manufacturers to produce generic versions of biologics.

    Previous regulations did not allow generic versions of biologics to be manufactured. Therefore, it was not possible to buy generic biologics. Recently, new laws have cleared the way for the possibility of generic biologics. HOWEVER, there is still quite a bit of rulemaking to be done.

    At this time, it is NOTentirely known when a generic version of Zevalin will be available. Even after the laws and regulations are changed to allow the manufacturing of generic biologics, it is likely that Zevalin will still be PROTECTED from generic competition by patents for several years.

    The medicine was approved by the U.S. Food and Drug Administration (FDA) in February 2002. It is not clear when the patents will expire, as the FDA does not yet list applicable patents for biologics like it does for other medications."

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    • What is the existing patent for???
      What are the other ongoing studies and additional cancer uses which are subject to additional patents and exclusivity periods?

      The current FDA approval is for one use or correct me if I am wrong. What about each and every other indication?

    • I would doubt that valid patents would have much life left. This was approved back in 2002, so figure the "invention" (including final tweeks) would have been around since the 90's. But that does not mean a biosimilar (the biologic equivalent of generics for small molecule drugs) will be on the horizon.

      First, though the FDA rules are not yet in place, one can assume some human trials would be needed. Safety (with a check for immune reactions), and a bioscan to see the radioactive distribution would seam reasonable. That takes money, and so does setting up the manufacturing.

      Second, biologics are expensive to make, so one can not grab market share by dropping the price way down.

      So you have a product with a relatively high cost of entry. And for a relatively modest benefit (Zevalin is not exactly a blockbuster).

      So why would somebody focus on this? Especially when there are dozens of billion dollar biologics to start working on biosimilars for.

      • 1 Reply to fib1_1_2_3_5
      • Patent was set to expire in 2015, but I think it was extended to 2016. But to my point, the pumpers still want to believe this drug is going to bring in hundreds of millions of dollars in revenue. It's not! I'm saying even if every oncologist suddenly began prescribing, the market would then become much more attractive and with limited patent life left, the entry of biosimilars would follow. Rituximab is definitely going biogeneric, so I think the overall $$ value of the anti-CD20 market is going to fall.

        Also, Kenny likes to talk about how SPI-2012 is going to compete in a $5B market. Well, there will definitely be G-CSF biosimilars coming to market there as well. I won't get into why this product will be a dud-extraordinaire, but I can tell you, this is a HUGE waste of SPPI's slowly dwindling resources.

        Sentiment: Sell

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