PHARMACY

Senators, U.S. Rep introduce bill to shorten length of biologics exclusivity

BY David Salazar
WASHINGTON — U.S. Rep. Jan Schakowsky and Sens. Sherrod Brown and John McCain on Thursday introduced a piece of legislation aimed at shortening the period of exclusivity for brand-name biologics products. The Price Relief, Innovation and Competition for Essential Drugs (PRICED) Act would amend the Public Health Service act to change the exclusivity period from 12 years to seven years. 
 
Brown said that the bill would “allow for more robust competition in the biologics market and provide for more new, equally effective biosimilars which will help provide more options for consumers and drive down prices.” According to an October 2015 report from the Government Accountability Office, Medicare Part B spent $4.418 billion on the highest-cost newly approved biologics in 2013. 
 
But the Biotechnology Innovation Organization, which represents biotechnology companies and related organizations, thinks the bill will harm biotech companies looking for new cures.
 
“BIO strongly opposes H.R. 5573 and its companion bill in the Senate,” BIO SVP federal government relations Jeanne Haggerty said. “This legislation would disrupt the careful balance, created by Congress with broad, bipartisan support in the Biologics Price Competition and Innovation Act (BPCIA), between the need to encourage investment in innovative, groundbreaking biological therapies and the desire to ensure that patients have increased choices offered by biosimilar products after a reasonable period of exclusivity for the innovator product. 
 
Haggerty said the 12-year exclusivity period is “an essential incentive for the huge risks associated with biotechnology investment,” as many biotech companies rely largely on venture capital to fund their innovations.
 
“Undermining investment in these companies means undermining investment in the next biomedical breakthroughs for patients,” she said. “This legislation is a short-sighted attempt to undercut the critical work that innovator companies are doing and would, if enacted, deprive patients of many new treatments and cures in the future.”
 
Schakowsky’s bill has been referred to the House Committee on Energy and Commerce. 
 
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BiPro USA unveils new whey protein flavor

BY Gina Acosta

EDEN PRAIRIE, Minn. — BiPro USA has added a strawberry flavor to its line of whey protein isolate powders.

With the new flavor, BiPro now has protein powders in the following varieties: unflavored, French vanilla, chocolate and strawberry.

BiPro's strawberry iteration stays true to the brand's clean label. The product contains just six ingredients, 90 calories per serving and zero grams of sugar. Just like every other BiPro flavor, strawberry carries 20 grams of protein per serving and is NSF Certified for Sport, ensuring that it is free of banned substances. The product is naturally sweetened and naturally flavored with real strawberry pieces.

"Formulating a strawberry protein powder that is clean, has minimal ingredients and tastes great was a major undertaking," said Polly Olson, vice president of sales, marketing and new business development. "You can see real pieces of dried strawberries in the powder which explains its wonderful smell. It provides exactly what athletes have come to expect from our brand and we're incredibly proud of the product we've created."

When BiPro USA launched in 2004, the brand only carried an unflavored protein powder. French vanilla and chocolate flavors were released in 2013. After strawberry's release, more exciting products are set to be announced in 2016.
 

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Mylan launches generic Avodart capsules

BY Gina Acosta

HERTFORDSHIRE, England and PITTSBURGH — Mylan announced Monday that it has launched Dutasteride Capsules, 0.5 mg, the generic version of GlaxoSmithKline's Avodart Capsules, in the U.S.

Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated as monotherapy for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention and reduce the risk of the need for BPH-related surgery. It may also be used with tamsulosin for the treatment of symptomatic BPH in men with an enlarged prostate.

Dutasteride Capsules, 0.5 mg, had U.S. sales of approximately $297.2 million for the 12 months ending April 30, 2016, according to IMS Health.

Currently, Mylan has 248 ANDAs pending FDA approval representing $107.6 billion in annual brand sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $37.2 billion in annual brand sales, for the 12 months ending December 31, 2015, according to IMS Health.

 

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