Six Considerations when Developing a Competitive Biosimilar Strategy in a Challenging Landscape

biosimilar strategy

Biopharmaceuticals (biologics) the most lucrative drugs on the market have revolutionized the business and practice of medicine. In 2012, seven of the top 10 best selling drugs were biologics, generating tens of billions of dollars in revenue. These drugs provide safe and effective treatments to some of the most challenging illnesses, however the high cost of some biologics burdens private and public insurers and can limit their availability to uninsured patients. (more…)

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Companion Diagnostics Essential Component of Precision Medicine

Companion diagnostics

At the beginning of this month the FDA released its much anticipated final guidance for companion diagnostics tests. It recognizes that those tests are evolving as essential components in order for new innovative therapies to be targeted to patients who will benefit the most. By and large, it contains no real surprises and lays out the definitions and approval processes that are needed to be followed to ensure the safety of the test designed to be used with a particular therapeutic. (See BioWorld Today, Aug. 4, 2014.) (more…)

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Five of the Most Promising Drugs Entering Phase III Trials

phase III trials

Ben Turner takes a look at five of the most promising drugs to watch that are entering phase III trials at the moment.

The first drug moving into phase III is targeted at the treatment of Pompe disease, a lysosomal storage disorder caused by an inherited deficiency in the lysosomal enzyme acid-alphaglucosidase (GAA). This deficiency leads to an accumulation of glycogen in myocyte lysosomes which in turn leads to cell death. It is a progressive degenerative disease which affects the heart muscle, diaphragm and skeletal muscle, causing muscle weakness, respiratory problems and enlargement of the liver and heart. There are two types of Pompe disease, adult onset, which affects around one in 57,000, and infantile onset, which affects approximately one in every 138,000. (more…)

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Ways to Prosper in the Increasingly Competitive Global Pharmaceutical Market

Global Pharmaceutical Market

The pharmaceutical environment, for both innovative R&D companies and generics manufacturers, continues to become increasingly competitive. For innovators, the recent patent cliff, higher regulatory hurdles, competitive pipelines, and the ever increasing cost of R&D are the drivers causing pressure on their business. Changing market and payer dynamics, increased competition and costs associated with API production, and regulatory challenges are doing the same for generics companies. Both sides are actively seeking new ways to alleviate these pressures and find new opportunities for growth. (more…)

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Sandoz: First Filer in the US Biosimilar Approval Pathway

Sandoz image

More than eight years after being granted approval for the first European biosimilar drug (Omnitrope in April 2006), Novartis’ generics arm, Sandoz, has again made history by being the first to file a drug for US approval via the new biosimilar approval pathway. This route to approval was created by the Biologics Price Competition and Innovation Act of 2009, which became law under the Patient Protection and Affordable Care Act in 2010. The subject of the filing is Zarzio, a bioequivalent version of Amgen’s Neupogen (filgrastim), which is a recombinant form of granulocyte colony-stimulating factor (G-CSF) used for treating neutropenia, including chemotherapy-induced neutropenia. Zarzio already competes with Neupogen in the EU, where it obtained approval in February 2009. However, the acceptance of the US filing in July 2014 potentially opens up a far more lucrative market to Zarzio: of Neupogen’s $1.526 billion revenue in 2013, more than 75% ($1.169 billion) came from US sales. (more…)

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Video: Strategic Insights from Xencor’s CEO

Xencor

Bassil Dahiyat, founder and CEO of Xencor Inc,. provided BioWorld with updates on Xencor’s two most advanced candidates: XmAb5871 for rheumatoid arthritis and XmAb7195, for severe asthma and allergic diseases. He also discussed the company’s transition from licensing its platform to now moving its first unpartnered and unoptioned candidate (Xmab7195) into the clinic. Finally, Bassil shared some frank thoughts on doing business in China. (more…)

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Sourcing API – Beyond India and China

sourcing api

Fifteen short years ago, India and China were emerging pharmaceutical markets content with supplying low-cost active pharmaceutical ingredients (APIs) to local customers. Today, these nations dominate the global bulk drug landscape, supplying regulated markets worldwide, with many Indian and Chinese companies now vertically-integrated and able to supply finished dose generics throughout the world. According to Thomson Reuters Newport, India and China combined have almost 2000 API manufacturers, a quarter of which are capable of supplying regulated markets. (more…)

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Will Adaptive Design Become the New Paradigm for Cancer Trials?

adaptive design

No one in biotech – industry, academia, regulators, nonprofits or patients themselves – disputes that cancer drug development is at a critical juncture. A raft of young companies has joined early movers in the space and the pipeline is filled with promising drugs. But the explosion of research in diagnostics and biomarkers – in conjunction with the recognition that cancer is an amalgamation of diseases rather than a handful of broad indications – is calling for a more stratified approach to drug development. (more…)

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Life Sciences Merger and Acquisitions in the 2nd Quarter of 2014

Life Sciences Merger and Acquisitions

The M&A activity in the Life Sciences sector in Q2 2014, as monitored on Thomson Reuters Recap was dominated by “tax inversions”, a strategy where a US based firm acquires a target company domiciled overseas in a country like Ireland or the Netherlands, that have lower tax rates. Companies employ a tax inversion strategy in order to reduce their tax burden. Many US-based pharma and medical device companies have already taken this route to escape US corporate tax system. (more…)

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Biotech’s Valuation Concerns Appear to be a bit of a ‘Stretch’

sovaldi

Back in March, Rep. Henry Waxman (D-Calif.) and several Democratic colleagues in Congress, wrote to Gilead Sciences Inc. requesting a briefing to answer questions about the pricing of the company’s hepatitis C drug Sovaldi (sofosbuvir). The Waxman letter got a lot of play in the media, triggering a massive sell-off in the biotechnology sector with investors worrying about a possible impending full court press on the costs of innovative new medicines by politicians, regulators and payers alike. (more…)

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