The Rapidly Evolving Business of Biosimilars

Biosimilars are to biologics what generics are to pharmaceuticals, still there are some key differences between the two. For instance, production of biologics and biosimilars requires living cell cultures as the starting point for production. Whereas pharmaceuticals and their generic counterparts do not.

Additionally, in order to determine the level of safety and effectiveness of a biosimilar drug candidate, the candidate will be required to undergo a reasonable amount of animal and/or human testing. To decide what constitutes a reasonable amount of testing will depend on the number of similarities between the biosimilar candidate and its innovator or reference product, according to Janet Woodcock, MD, head of the FDA’s Center for Drug Evaluation and Research.

In February 2012, the FDA released a preliminary guide outlining what would be required of companies wanting to break into the biosimilar market. It stated that the makers of these products will be required to present data from analytical studies to show how similar their biosimilar product is to the original FDA-approved biological reference product.

“These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers, said Woodcock. Groundbreaking innovations like biosimilars are something we want to get behind. We want to bring researchers and manufacturers together to help propel advancement.”

Still, one problem that plagues the biologic and biosimilar markets is immunogenicity – a patient’s antibody reaction to a biological drug which the body perceives to be a foreign micro-organism or virus. This is a problem that does not present itself in pharmaceuticals because they are not produced from living cell cultures. Although the generic versions of pharmaceuticals can differ slightly from the reference product they are more easily produced due to the nature of their small molecules. Biosimilars on the other hand, have to mimic the high molecular complexity found in biologics which also carry the added trouble of being an unstable living cell. Furthermore, the body must accept biologics and biosimilars as genuine to the recipient’s system. At this time producing precise duplications of the active ingredients contained in a biologic would be a kin to cloning; thus biosimilars are as “similar” as current scientific production allows.

Moreover, there is always the added difficulty of attracting patients to participate in biosimilar clinical trials. Especially where serious diseases are concerned, patients often are reluctant to participate in clinical trials due to the uncertainty about which product they will be receiving – the unapproved biosimilar or the approved and branded biologic.

Of course, biosimilars follow a business model that aims to produce copies of the originals at a fraction of the cost, and then to offer the resulting products at a lesser price than their original counterparts. And, while this is a window of opportunity to help save more lives by offering the medication at a more affordable price, it is also an opportunity to take advantage of the potentially big business of biosimilars.

“The great economic advantage of biosimilars is that a manufacturer only needs to recreate the idea that has already been shown to work,” said Joseph Miletich, MD, PhD, Amgen’s senior vice president of R&D.

As with any subset of the medicine producing industries,

Competition within the biosimilar industry is expected to be fierce. It is already apparent that larger, well-established companies will be most likely to dominate the market and alliances will likely become even more important in an effort to offset some of the risk and uncertainty that comes along with the new advancement and industry. This is especially important when you consider that the market has not yet grown as fast as expected. Luckily, the overwhelming public demand for lower healthcare and drug costs, as well as the increasing availability of such lifesaving drugs, point to an upswing and growth for the biosimilar market.

Different Types of Medical Transportation

Medical transportation has existed ever since injured people have needed to be taken to the nearest healer or doctor. Ancient Greek and Roman soldiers have sometimes carried off the line of battle on their shields. For high-ranking officials and military leaders, a chariot might be used to speed the evacuation. In later wars, horse-drawn carriages would ferry soldiers from the fighting to the aid station. In small towns, an ambulance was often unnecessary, as the local doctor would visit the infirm in their own homes. Today, the most common way to get an injured person to a hospital or treatment location is with an automobile ambulance. However, there are many other forms of ambulances throughout the world. Here are three ways, other than automobiles, that people are taken to hospitals.

Helicopter

After automobiles, the most common form of medical transportation, at least in the United States, is the helicopter. Helicopters first saw major use as transport vehicles during the Korean War. The United States military showed how effectively they could be used to deliver troops to remote locations, and retrieve them quickly when needed. Today, helicopters are used for very severe injuries, where every second gained is vital to the survival of the patient. A helicopter can carry a patient from the scene of an accident to a nearby hospital in significantly less time than a traditional ambulance. Along with the greater speed of a helicopter, which can reach up to 250 mph, it also does not have to contend with the traffic and other obstacles that any road poses. Helicopters are also used to pick patients up from remote locations that are inaccessible to other means of transport, such as islands, wilderness, and mountaintops.

Ship

When accidents occur on lakes, around islands, or along the coast, water ambulances are often used to carry survivors to the nearest hospital. Due to their larger size, these ships usually have several trained personnel on board, as well as more, and better, equipment, when compared to an automobile. For accidents that happen far out to sea, coast guards around the world will aid injured passengers and take them to the nearest land to receive treatment. In severe cases, a helicopter may be dispatched to pick up a patient from a ship while still at sea. Due to the remote nature of the sea, and the obligation any vessel has to respond to a distress call, commercial cargo ships, fishing boats, and private yachts often provide medical transportation as well.

Plane

By far the least commonly used medical transportation method, planes are nonetheless important. The most common use of planes to transport patients is when a patient needs to receive treatment at a specific facility. This might be because the facility has the best surgeon in a particular field or is where the person donating an organ is located. Although rarely used, plane ambulances can save lives.

Present and Future of Telemedicine & Telemedicine Providers

Present State of Telemedicine:

Today, the field of telemedicine is changing faster than before. The exponential growth of technology in recent years has led to an increase in the affordability and accessibility of telemedicine services. Telemedicine providers offer 24/7 access to medical care, staffing solutions for hospitals and virtual visits to doctors.

With the popularity of smartphones on the rise, a wide variety of mobile applications have been developed by telemedicine providers for easy monitoring of consumer health. Simple portable devices have been designed for monitoring body vitals such as glucose levels and blood pressure for a patient’s use at home.

Clinical Guidelines for Telemedicine:

Almost every service has a set of established guidelines to be followed, and telemedicine is no exception. While telemedicine providers and users are yet to have a standard set of guidelines, the American Medical Association (AMA) has put together a set of clinical guidelines pertaining to telemedicine services, some of which are as follows:

When to use: Telemedicine should not be used for medical conditions that require in-person examination by a licensed physician or doctor.

Notifying the patient: It is necessary for telemedicine providers to inform the patient in advance about how telemedicine services work, the limits of technology to be used and the communication protocols.

Patient evaluation and management: It is the duty of healthcare service providers to determine the appropriate telemedicine service for a patient.

They are responsible for the following:

• Determining the requirements of the patient.

• Connecting the patient with a suitable physician/doctor.

• Recording patient data for use in diagnosis and storage in database.

Billing information: Telemedicine providers should keep their patients informed of the medical costs beforehand.

Barriers for Telemedicine:

Although telemedicine is gradually gaining popularity, it has to overcome a few barriers that stand in its way of widespread usage, such as administrative barriers, state legislation restrictions, state-specific licensing requirements and patient-doctor reimbursement policies.

The Future of Telemedicine:

Market analysts predict that telemedicine will be a $36.3 billion industry by 2020.

In a group of patients who were surveyed, 75% of them reported their interest in telemedicine services and predict a bright future for it.

Advancements in the fields of technology such as virtual reality, coupled with a constantly growing user-base of telemedicine services reveal an exciting future for telemedicine. Robotic arms which can be controlled remotely and smart watches, which connect to health-trackers via wireless network or Bluetooth to instantly notify the user of any discrepancies will play an important role in telemedicine in the not-so-distant future.