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The US pharmaceutical industry is on the brink of a new ecosystem — but it's not taking off as smoothly as expected.

Up until the past few years, biologic drugs made from living cells didn't face competition once they lost patent protection. That's been changing with the introduction of drugs called biosimilars. But their rollout hasn't exactly been the game-changing experience some had expected.

"We believe that biosimilars will capture meaningful market share, but the disappointing commercial success so far with less than $2 billion annual sales illustrates that the bar is high," Morgan Stanley analysts said in a report on Wednesday. That's in large part because of the economic challenges that biosimilars face, the report says. 

Biosimilars are a bit more complicated than your average competing medicine: Unlike generics for chemical-based drugs like antibiotics that can be interchangeable with branded versions, the copycats of biologic medications, produced using living cells, have a few more caveats. 

As it stands right now, biosimilars can't be used interchangeably with branded versions, meaning if you were to get a prescription for a branded biologic, you wouldn't be able to opt for the "generic" one at the pharmacy as easily as you could if the drug was, say, a statin. 

It also takes more time, energy, and money to get a biosimilar approved, compared to a generic medicine. To develop a biosimilar, it usually takes about eight years and can costs about $250 million. In comparison, a generic takes a quarter of that time (about two years) and costs a tenth of the price ($5 million) to produce.

Having more biosimilars in the US would be a big deal: It might be the best way to drive down the cost of biologic medications that have been around for a while. The savings of putting people on far less costly biosimilars — even just new patients who have never taken the original — are estimated to be billions of dollars. Express Scripts, a pharmacy benefit manager, estimated in 2013 that the US could be saving $250 billion over the next 10 years because of biosimilars.

The biologic medicine market is roughly $200 billion, according to Morgan Stanley, which makes that $2 billion a bit lackluster.

The biosimilars haven't come at much of a discount to their branded counterparts (between 15% to 30% discounts to the branded drug's list price, compared to generics that can typically charge 80-90% off the branded version). As a result of the still-relatively high cost, many people haven't transitioned over to biosimilars in the same way people have observed with generic drugs.

"While we acknowledge that biosimilars could represent a real sales opportunity, we believe that the economics of biosimilars remains challenged," the note said.

Morgan Stanley highlighted a few "winners," companies that are in the best position to make a profit off biosimiars, both from a company perspective and the drugs they're going after. Celltrion, Sandoz and Amgen are best placed, according to the US bank. 

Screen Shot 2017 04 05 at 4.55.36 PMMorgan Stanley

Trump's pick to lead the FDA, Dr. Scott Gottlieb echoed the disappointment in his hearing before a Senate committee Wednesday. 

"Many of us have been disappointed by the economic savings we’ve seen from biosimilars so far," Gottlieb said. "But I do think there’s a lot of opportunity for these to have meaningful impact on consumers and spending going forward."

Gottlieb also pointed to some approaches he might take as commissioner, such as addressing whether biosimilars could be used interchangeably, like how generics are used.

With those changes, it's possible the future of biosimilars could shake out closer to expectations.

Courtesy of BusinessInsider

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The Winners And Losers Of A Cashless Society

Courtesy of: The Money Project


There is a global push by lawmakers to eliminate the use of physical cash around the world. This movement is often referred to as “The War on Cash”, and there are three major players involved:

1. The Initiators
Governments, central banks.
The elimination of cash will make it easier to track all types of transactions – including those made by criminals.

2. The Enemy
Criminals, terrorists
Large denominations of bank notes make illegal transactions easier to perform, and increase anonymity.

3. The Crossfire
The coercive elimination of physical cash will have potential repercussions on the economy and social liberties.

Is Cash Still King?

Cash has always been king – but starting in the late 1990s, the convenience of new technologies have helped make non-cash transactions to become more viable:

  • Online banking
  • Smartphones
  • Payment technologies
  • Encryption

By 2015, there were 426 billion cashless transactions worldwide – a 50% increase from five years before.

Year # of cashless transactions
2010 285.2 billion
2015 426.3 billion

And today, there are multiple ways to pay digitally, including:

  • Online banking (Visa, Mastercard, Interac)
  • Smartphones (Apple Pay)
  • Intermediaries ( Paypal , Square)
  • Cryptocurrencies (Bitcoin)

The First Shots Fired

The success of these new technologies have prompted lawmakers to posit that all transactions should now be digital.

Here is their case for a cashless society:

Removing high denominations of bills from circulation makes it harder for terrorists, drug dealers, money launderers, and tax evaders.

  • $1 million in $100 bills weighs only one kilogram (2.2 lbs).
  • Criminals move $2 trillion per year around the world each year.
  • The U.S. $100 bill is the most popular note in the world, with 10 billion of them in circulation.

This also gives regulators more control over the economy.

  • More traceable money means higher tax revenues.
  • It means there is a third-party for all transactions.
  • Central banks can dictate interest rates that encourage (or discourage) spending to try to manage inflation. This includes ZIRP or NIRP policies.

Cashless transactions are faster and more efficient.

  • Banks would incur less costs by not having to handle cash.
  • It also makes compliance and reporting easier.
  • The “burden” of cash can be up to 1.5% of GDP, according to some experts.

But for this to be possible, they say that cash – especially large denomination bills – must be eliminated. After all, cash is still used for about 85% of all transactions worldwide.

A Declaration of War

Governments and central banks have moved swiftly in dozens of countries to start eliminating cash.

Some key examples of this? Australia, Singapore, Venezuela, the U.S., and the European Central Bank have all eliminated (or have proposed to eliminate) high denomination notes. Other countries like France, Sweden and Greece have targeted adding restrictions on the size of cash transactions, reducing the amount of ATMs in the countryside, or limiting the amount of cash that can be held outside of the banking system. Finally, some countries have taken things a full step further – South Korea aims to eliminate paper currency in its entirety by 2020.

But right now, the “War on Cash” can’t be mentioned without invoking images of day-long lineups in India. In November 2016, Indian Prime Minister Narendra Modi demonetized 500 and 1000 rupee notes, eliminating 86% of the country’s notes overnight. While Indians could theoretically exchange 500 and 1,000 rupee notes for higher denominations, it was only up to a limit of 4,000 rupees per person. Sums above that had to be routed through a bank account in a country where only 50% of Indians have such access.

The Hindu has reported that there have now been 112 reported deaths associated with the Indian demonetization. Some people have committed suicide, but most deaths come from elderly people waiting in bank queues for hours or days to exchange money.

Caught in the Crossfire

The shots fired by governments to fight its war on cash may have several unintended casualties:

1. Privacy

  • Cashless transactions would always include some intermediary or third-party.
  • Increased government access to personal transactions and records.
  • Certain types of transactions (gambling, etc.) could be barred or frozen by governments.
  • Decentralized cryptocurrency could be an alternative for such transactions

2. Savings

  • Savers could no longer have the individual freedom to store wealth “outside” of the system.
  • Eliminating cash makes negative interest rates (NIRP) a feasible option for policymakers.
  • A cashless society also means all savers would be “on the hook” for bank bail-in scenarios.
  • Savers would have limited abilities to react to extreme monetary events like deflation or inflation.

3. Human Rights

  • Rapid demonetization has violated people’s rights to life and food.
  • In India, removing the 500 and 1,000 rupee notes has caused multiple human tragedies, including patients being denied treatment and people not being able to afford food.
  • Demonetization also hurts people and small businesses that make their livelihoods in the informal sectors of the economy.

4. Cybersecurity

  • With all wealth stored digitally, the potential risk and impact of cybercrime increases.
  • Hacking or identity theft could destroy people’s entire life savings.
  • The cost of online data breaches is already expected to reach $2.1 trillion by 2019, according to Juniper Research.

As the War on Cash accelerates, many shots will be fired. The question is: who will take the majority of the damage?

Courtesy of Infographics

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"In an ideal world everyone would generate sufficient savings on their own to help fund their own retirement. However most of the data shows that Americans are simply unable to do this on their own. Nor is the current system of savings consisting of 401(k)s and IRAs doing the job either. The next few generations may now be facing increasingly difficult retirement scenarios. The question is whether instituting real changes now can help save future generations from a similar fate."  Read the full post @ Abnormal Returns

My knee-jerk reactions are several:

  1. Tell this to a worker earning $7.50-10.00/hour paying $3.89/gallon for gasoline that he'll have no choice but contribute 9% pre-tax to a retirement account and the premise becomes something of an outrage.
  2. I can see this already as yet another "account" which the US would borrow from a la Social Security (and still hasn't repaid).
  3. It's yet another scheme to increase inflows into investment vehicles which obviously broker/dealers (banks) would love.........but wait do small investors always benefit from investing?  Tell that to a retiree whose 401k was wiped out twice in 10 years and who has now been forced back into the labor force........and you may have a tough sell. 

Of course if they shouldn't do it is precisely why they probably will...... 

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