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odac 2017

Understanding and Using Biosimilars

By Medical Dermatology, ODAC Sessions, Patient Care
Dr Leon Kircik at ODAC Dermatology Conference

Source: Dermatology Times

One of the only things the dermatology community knows about biosimilar use is that there are many unknowns. Still, biosimilars are on dermatologists’ radars as having the potential to lower the high costs of biologic treatments for chronic skin diseases, including psoriasis.

There also are misperceptions—even among dermatologists—about what biosimilars are and if these drugs can be used to treat patients, according to Leon H. Kircik, M.D., clinical associate professor of dermatology at Indiana University School of Medicine, Indianapolis; clinical associate professor of dermatology at Mount Sinai Medical Center, New York City; and medical director of Physicians Skin Care in Louisville, Ky. who presented “Biosimilars: What You Need to Know” at the Orlando Derm Aesthetic and Clinical conference in Miami, Fla., in January 2017.

Misperception number one

The first misperception is that biosimilars are generic biologics. They’re not, he says.

“You cannot have a generic of a biologic because every biologic is made differently. So, it is important for everybody to understand that biosimilars are not generics,” says Dr. Kircik,

As a result, the approval process for biosimilars is different for that of generics. Biosimilars came about because of the Biologics Price Competition and Innovation Act of 2009, which passed in Congress as a provision of the Affordable Care Act. Biosimilars have an abbreviated licensure pathway, but it’s a different pathway compared to a generic.

“Biopharmaceuticals are biopolymers of organic molecules that are manufactured in living systems. Function is based not only on the amino acid number and sequence but also on posttranslational modification (e.g. glycosylation) that are added by virtue of manufacture in living systems.”

Complexities and blurred lines

The FDA’s definition of a biosimilar, according to Dr. Kircik is, “A biological product that is highly similar to the reference product, notwithstanding minor differences in clinically inactive components. There are no clinically meaningful differences from the reference product in terms of the safety, purity, and potency”

“Those are very vague terms,” Dr. Kircik says.

The first biosimilar (not for use in dermatology), Zarxio [Sandoz], was FDA approved in March 2015. Zarxio is biosimilar to Neupogen (Amgen, filgrastim)1

More than a year later, the first biosimilar to have dermatologic indications received FDA approval—a biosimilar of infliximab, by the name of Inflectra (Celltrion). Interestingly, Inflectra, a biosimilar to Janssen Biotech’s Remicade, has an indication for psoriasis but no data on dermatologic disease, including psoriasis, Dr. Kircik says.

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Nasal Reconstruction After Surgery

By Aesthetic Dermatology, Medical Dermatology, ODAC Sessions, Surgical Dermatology
Explore By Region

Source: Dermatology Times

Options for repairing nasal defects after skin cancer surgery should be based on location, size and depth of the defect, as well as patient preference.

“If the defect is centrally located in the alar groove, you may want natural healing to occur,” says Joel L. Cohen, M.D., associate clinical professor of dermatology at the University of Colorado in Denver, and director of AboutSkin Dermatology in Greenwood Village and Lone Tree, Colo. He spoke with Dermatology Times prior to his presentation on skin cancer nasal reconstruction at the recent Orlando Dermatology Aesthetic & Clinical Conference (ODAC) in Miami.

“In such a case, the natural concavity is often recapitulated by simply letting the skin granulate, without the need for any sutured repair.”

However, in many instances of nasal reconstruction, dermatologists have to decide which procedure will achieve the best aesthetic outcome and also, the level of wound care that can be managed by the patient.

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Laser Resurfacing for Minimizing Post Surgery Scars

By Aesthetic Dermatology, Medical Dermatology, ODAC Sessions, Patient Care, Surgical Dermatology
Adam Friedman, MD at ODAC Dermatology Conference

Source: Dermatology News

In his practice, Joel L. Cohen, MD, spends a good part of his day doing Mohs surgery, “with the goal of cancer removal, and after surgery, having the patient look good,” he said at the Orlando Dermatology Aesthetic and Clinical Conference.

“Having resurfacing in my practice has allowed me to treat not only wrinkles and etched lines, but also help skin cancer patients by blending and minimizing their skin cancer scars,” said Dr. Cohen, an aesthetic dermatologist and Mohs surgeon in private practice in Denver.

For example, one of his patients was a kindergarten teacher who had a large rotation flap scar on her cheek after excision of a melanoma in situ. The children asked her about it all the time during the 2 months after the surgery, and she decided to come in for some laser sessions. “With three ablative fractional laser sessions, she really looked great just 3 months later and wasn’t even interested in wearing makeup at that point.”

Resurfacing in his practice using a variety of lasers is very helpful, Dr. Cohen said. He published a study in November that compared pulse dye laser, CO2 ablative fractional lasers, or a combination of both for modification of scars following Mohs surgery (J Drugs Dermatol. 2016 Nov 1;15[11]:1315-9).

The prospective, multicenter study revealed that although both monotherapy approaches were safe and effective, the combination of pulse dye laser and fractional ablative laser offered some synergy that was preferred by patients.

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FDA Approval: Corticosteroid-Sparing Topical for Eczema

By Medical Dermatology, ODAC Sessions, Patient Care
Dr. Friedman Presenting at the ODAC Dermatology Conference

Source: Dermatology Times

The FDA announced it has approved Eucrisa (Anacor Pharmaceuticals, crisaborole) ointment to treat mild to moderate eczema in patients two-years-of-age and older.

Applied twice daily, Eucrisa is a phosphodiesterase 4 (PDE-4) inhibitor. Its precise mechanism of action in atopic dermatitis, however, isn’t known, according to an FDA press release.

“We welcome this corticosteroid-sparing topical option,” says Elaine C. Siegfried, M.D., professor of pediatrics and dermatology at Saint Louis University, Cardinal Glennon Children’s Hospital, St. Louis, Mo. “The other two alternatives (pimecrolimus cream and tacrolimus ointment) carry black box warnings and labelled limitation on duration of use. Although most pediatric dermatologists prescribe these medications in infants and children without long-term safety concerns, prescribing Eucrisa is not hampered by this medicolegal burden. However, cost and access could be a limitation.”

Adam Friedman, M.D., associate professor of dermatology and director of translational research in dermatology at George Washington School of Medicine and Health Sciences, tells Dermatology Times that this most recent approval represents the exciting first of hopefully many new approved therapies for an exceedingly common disease state, which until recently was largely ignored.

“I envision crisaborole being used in a similar manner to calcineurin inhibitors, both as proactive treatment for affected delicate areas like the eyelids, face, body folds, groin or mild disease elsewhere. But, more importantly, [I envision it] as preventative maintenance therapy for disease areas that recur frequently after topical steroid use has been discontinued (though without the baggage of a black box warning and possible substance P induced burning at the onset of use),” he says.

Dr. Friedman, who is presenting on the topic of eczema at the January 16 to 19, 2017 Orlando Derm Aesthetic and Clinical conference in Miami, Fla., says this approval, however, should not overshadow the basic and requisite elements for properly managing this often chronic condition. These basics are: clear patient education on a broad range of topics, including realistic expectations; proper soap, moisturizer and treatment use; and myths about treatment safety, in order to gain the patient’s confidence, which in turn, increases the likelihood of regimen compliance, according to Dr. Friedman.

Taming Atopic Dermatitis and Managing Expectations

By Medical Dermatology, ODAC Sessions, Patient Care
Adam Friedman, MD faculty headshot

Source: Dermatology News

Tactics for managing patients with atopic dermatitis can go a long way to educate patients, set realistic expectations, and devise strategies for existing therapies, even as clinicians await some promising agents expected on the market soon.

“The good news is this is the Age of Eczema. In the last couple of years we’ve seen an explosion in the literature,” Adam Friedman, MD, of the department of dermatology, George Washington University, Washington, D.C., said at the Orlando Dermatology Aesthetic and Clinical Conference. Some of this research is spurring new therapeutics. a phosphodiesterase 4 inhibitor.

Crisaborole ointment, 2% (Eucrisa), a phosphodiesterase 4 inhibitor, was approved by the Food and Drug Administration in December 2016 for treating patients aged 2 years and older with mild to moderate AD, for example. It is a novel, nonsteroidal anti-inflammatory and the first prescription agent approved in the United States for atopic dermatitis in more than 10 years.

Dr. Friedman has no personal experience with crisaborole, which just became available. “But the data look encouraging. From what I’ve seen this may be a nonburning alternative to calcineurin inhibitors. It will be interesting to see how this will fit in our practices.”

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